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The Standard Operating Procedures (SOPs) in this library have been established to ensure consistency and compliance with Federal & State regulations, institutional policies, and Good Clinical Practice guidelines that are common to clinical research of all types. By standardizing these SOPs, we are aligning our clinical research activities across campus with the 1U4U vision.

The SOPs in this library define clinical research and clinical trial as:

Standard Operating Procedure Library  

• UUSOP-01 STANDARD OPERATING PROCEDURE PROCESS
• UUSOP-02 FDA INSPECTIONS
• UUSOP-02-A FDA INSPECTIONS SUPPLEMENT A
• UUSOP-03 PROTOCOL TRAINING FOR INVESTIGATORS AND STUDY STAFF
• UUSOP-04 INVESTIGATOR RESPONSIBILITIES
• UUSOP-05 DELEGATION OF AUTHORITY
• UUSOP-06 STUDY RECORDS MANAGEMENT
• UUSOP-06-A STUDY RECORDS MANAGEMENT SUPPLEMENT A
• UUSOP-07 DEVIATIONS: DOCUMENTATION AND REPORTING
• UUSOP-08 OBTAINING WRITTEN INFORMED CONSENT
• UUSOP-09 CASE REPORT FORM COMPLETION STANDARD
• UUSOP-10 MONITORING VISITS FOR EXTERNALLY SPONSORED CLINICAL TRIALS
• UUSOP-11 Investigational New Drug Applications in FDA-Regulated Research
• UUSOP-12 Investigational Device Exemption Applications in FDA-Regulated Research
• UUSOP-13 CLINICAL RESEARCH INSTITUTIONAL FEE SCHEDULE
• UUSOP-13-A CLINICAL RESEARCH INSTITUTIONAL FEE SCHEDULE SUPPLEMENT A – COST STRUCTURE RATIONALE
• UUSOP-14 Clinical Trial Safety Assessment and Reporting
• UUSOP-15 internal monitoring of university of utah clinical studies

UPDATES TO CLINICAL RESEARCH SOPS

SUGGESTIONS FOR CLINICAL RESEARCH SOPS

CRCG BYLAWS

ADDITIONAL U OF U SOPS AND POLICIES

CONTACT CRCG

CRCG OFFICERS & MEMBERSHIP

Who should use these?

This library of Standard Operating Procedures is a resource for anyone conducting clinical research at the University of Utah as applicable to the research being done. 

As a research institution, the University of Utah must comply with laws, policies and regulations established by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), the International Conference on Harmonization guidelines (ICH), and the State of Utah. 

Our University clinical research SOPs define processes in-line with the laws, policies and regulations governing human subject research and should be utilized by all personnel conducting such research at the University of Utah. 

My department already has SOPs on these topics but they have more details specific to my group. Which SOPs should I use?

In an effort to standardize all clinical research efforts at the University, and to align with the 1U initiative, the Office of Quality Compliance highly promotes the utilization of these SOPs.  However, if additional details or processes specific to individual departments/divisions need to be followed, Working Guidelines should be developed as a supplement to the SOPs in this library. 

Departmental leadership or their delegates should develop these Working Guidelines for use by the individual departments/divisions.  Any department/divisional Working Guidelines should not conflict with the SOPs in this library and should follow the same basic principles and standards.

What do I do with my current SOPs?

Any SOPs that are of the same topic and similar process should be retired and the University SOP should be implemented. Each group is encouraged to create supplemental working guidelines as needed to further direct their department/study processes. 

What should I do if there are procedures in the SOP that cannot be followed by our individual team?

Every effort should be made to adhere to the processes outlined in these SOPs.  If an exception to an SOP is needed, the department should clearly document, in writing, what part of the SOP cannot be adhered to and an alternative process that will be followed.

What is the difference between an SOP and a guideline or work practice document (WPD)?

An SOP is the chief document to describe what is to be done for a given procedure, who is responsible for doing it, and when it is to be performed. If instructions on how to perform the procedure are relatively simple, they may be included in the SOP.

However, if the steps are especially detailed or change depending on department practices then a separate, department-specific Guidance Document/WPD should be created to describe the full details.

A Guidance or Work Practice Document is a supportive document that describes in detail   how a specific procedure is to be performed or suggest direction on operational processes and workflows. Refer to UU SOP-01 , Sections “Definitions and Acronyms”, 1.1. and 2.2.

I have other SOPs on topics that are not found in this library, what do I do with those?

You can continue to utilize your other SOPs as long as they do not contain contradicting processes to the SOPs in this library.

How should teams be trained on these SOPs?

Training and documentation of training should be carried out by the individual departments as part of their current training plan. 

Optional Resources

• If you need an example of a general training log, please  see this link .
• A certificate to document review of each SOP can be obtained here .

Will I be held accountable?

The Office of Quality Compliance may conduct periodic audits to identify areas where researchers may need additional training, or to alert the office of any SOPs that should be created or amended.

Whom should I contact with questions or concerns?

Please submit any questions or comments and someone from the SOP Collaboration Team will contact you within 2-3 business days.

U of U SOPs Contact Us

What is the CRCG Clinical Research SOP Development Process?

Clinical research sop development process.

1 SOP needs are identified by the following methods:      •  Request from University employee (either by email to [email protected]   or through the CRCG web form )      •  Multiple Google searches for specific content (identified through Google analytics report)      •  Need identified and suggested by CRCG member(s) 2 CRCG is the Clinical Research SOP Collaboration Group. 3 CRCG approval is performed by voting members, according to bylaws . 4 CRC is the Clinical Research Committee, chaired by the School of Medicine Associate Dean of Clinical Research. 5 VPR is the Vice President for Research

How are Source Documents, study worksheets, and Case Report Forms (CRFs) similar and different? A comparison of purpose, creation, and use. 

FAQ - Source Documents vs CRFs vs Worksheets

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Downloadable Templates and Tools for Clinical Research

Welcome to global health trials' tools and templates library. please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. please click on the orange text to download each template., the templates below have been shared by other groups, and are free to use and adapt for your researchstudies. please ensure that you read and adapt them carefully for your own setting, and that you reference global health trials and the global health network when you use them. to share your own templates and sops, or comment on these, please email [email protected]. we look forward to hearing from you.

These templates and tools are ordered by category, so please scroll down to find what you need.

To share your own templates and SOPs, or comment on these, please email [email protected]. We look forward to hearing from you!

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This is Degena Bahrey Tadesse from Tigray, Ethiopia. I am new for this web I am assistant professor in Adult Health Nursing Could you share me the sample/templet research proposal for Global Research Nurses Pump-priming Grants 2023: Research Project Award

I have learned lot..Thanks..

i was wondering why there is no SOP on laboratory procedures ?

Hi, Can you provide me the SOP for electronic signatures in Clinical trial

Do you have an "SOP for Telephonic site selection visit". Kindly Share on my registered mail ID

Thank you for sharing the resources. It is very kind of you.

Hi These tolls are very useful! Thank you

Do you have a task and responsability matrix template for clinical trial managment ? Best

I am very much happy to find myself here as a clinician

Dear Getrude

We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

Kind regards The Editorial Team

need modules on free online gcp course on research ethics

Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

Dear Nazish

Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrainingcentre.tghn.org/webinars/ , and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course. If you need anything else, do ask! Kind regards The Editorial Team

Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

This site is impeccable and very useful for my job!!!!

Thank you for your kind comments.

Fantastic resources

I am delighted you found this website. I earlier introduced it to you because of your prolific interest in health care information and resource sharing....

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SOPs: A Must for Sites

Applied Clinical Trials

Detailed instructions for creating strong SOPs that can serve as the backbone of studies and sites.

Standard Operating Procedures (SOPs) are detailed, written instructions that specifically describe how to complete research-related activities; they are statements of who does what, where, when, why, and how. SOPs serve to document what has been agreed and adopted as standard practice. Well-written and well-managed SOPs provide an official and standard way to consistently execute required research-related activities. In addition, they can improve communication among staff, reduce dependence on individuals with institutional knowledge, and improve efficiency of staff training.

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SOPs for Clinical Research

Ighid clinical research sop template overview.

The SOP templates offered on this site are geared towards outpatient clinical research. They can be used by any research site around the world but their focus is on sites who are part of the Institute for Global Health and Infectious Diseases at UNC. Developing SOPs and procedures is a time-consuming process that requires years of experience and dedicated administrative time. These templates are a resource designed to expedite the process of site readiness. They are easily adapted with highlighted areas geared to stimulate discussion at the site on how make a process work for your local context.

The SOP categories are divided into Administrative, Principal Investigator (PI) oversight, Clinical Management and Participant Safety, and Data Management. The Tools for Research folder provides quick access to well-developed and commonly used tools in research.

IGHID Regulatory has a set of SOPs focused on IRB submissions and maintenance of essential documents. Please email the IGHID Regulatory Director, Tania Hossain at [email protected] to request access. Pharmacy and laboratory SOPs are not included. For laboratory processes, please contact the UNC Global CTU Laboratory Manager, Amy James at [email protected]

SOP Development

The SOPs are adapted from experienced IGHID research projects and encopmas studies that undergo regular site monitoring from DAIDS and Industry sponsors along with sponsor audits. The SOPs and workflows described have been refined over the years and have produced clear staff roles, a focus on continuous quality improvement, participant safety, and high-quality data.

How to use the Templates

Each SOP template is housed in Microsoft Office Word OneDrive document. The original documents are locked for editing but once copied, you can edit as needed. Each document has comments or red writing to indicate what information is most likely need to be adapted to your site. Please note that this is a complete set of SOPs that cross-refers to other SOPs in the set. The References section lists each SOP that is cross-referenced. If you are using a single SOP as an addition to your own set, update the Reference section to direct the reader to the correct SOP. Headers and footers in the document can only be viewed when the document is opened in the desktop Microsoft Word application.

UNC ONYEN Affiliates

All UNC affiliates with an ONYEN should be able to open the word documents below that are housed on an internal UNC SharePoint site. If you would like to copy the entire SharePoint (SP) site, please request access below. You can copy the OneDrive folder or SharePoint site, then modify all the documents on your own site. The advantage of having the SP site is that all the SOPs can be easily organized at a glance with who is document owner, dates for renewal or archive, and more. The SOP list and all the columns associated with the SOPs can be exported into an excel document.

UNC Non-Onyen Affiliates

If you are a UNC affiliate without an ONYEN, please request access below to the SharePoint site. Please note which UNC research site you are affiliated with and the site PI.

Administrative (AD)

• IGHID Clinical Research Acronyms and Definitions Template
• SOP – AD-00 – IGHID Clinical Research SOP Template
• SOP – AD-01 – SOP Creation, Review and Training Template
• SOP – AD-02 – Deferring to IGHID and Outside Group’s SOPs Template
• SOP – AD-03 – Protocol Training Template
• SOP – AD-04 – Site Staff Responsibility and Communication of Protocol Implementation Template
• SOP – AD-05 – Language Requirements for Research Staff Template
• SOP – AD-06 – Monitoring Visits Staff Responsibilities Template

Clinical Management and Participant Safety (CS)

• SOP – CS-01 – Study Start-up Meeting Template
• SOP – CS-02 – Serious Adverse Event (SAE) and Expedited Adverse Event (EAE) Template
• SOP – CS-03 – Adverse Event (AE) Management Template
• SOP – CS-04 – Recruitment, Screening, Enrollment and Retention of Study Participants Template
• SOP – CS-05- Blood Volume Monitoring Template
• SOP – CS-06 – Scope of Practice for Non-Licensed Clinical Staff Template
• SOP – CS-07 –  Infectious Disease Counseling, Testing and Referral Template
• SOP – CS-08 – Co-Enrollment Prevention Template
• SOP – CS-09 – Unblinding Study Participants Template
• SOP – CS-10 – Investigational Product Transport and Temporary Storage Template
• SOP – CS-11 – Pharmacy Responsibilities Template
• SOP – CS-12 – Physical Exam Template
• SOP – CS-13 – Obstetric Referral Plan Template
• SOP – CS-14 – Medical Management at the Research Location Template
• SOP – CS-15 – Infection Control at the Research Location Template
• SOP – CS-16 – Suicidal and Homicidal Study Participant Management Template

Data Management (DM)

• SOP – DM-01 – Source Documentation and Data Collection Guidelines Template
• SOP – DM-02 – Research Quality Management, CRF Completion and CAPAs Template
• SOP – DM-03 – Data Access, Security and Facilities Template
• SOP – DM-04 – Screening and Enrollment Logs Template
• SOP – DM-05 – Paper Source Documentation Development and Research Record Organization Template

Principal Investigator Oversight (PI)

• SOP – PI-01 – Supervision of Clinical Trials Staff Template
• SOP – PI-02 – Delegation of Duties (DoD) log Template

Tools for Research

• Data Management Tools
• Regulatory Tools
• Source Document Tools
• Visit Checklist Templates
• Visit Logs Templates

Your Feedback is essential!

Research requires continuous quality improvement in all areas.

Please let us know if you would like access to the SharePoint site to copy (available to UNC Affililiates only), have a suggestion, or need an SOP for your site.

SOP Clinical Research Feedback

Contact information, do you have an sop to share with ighid.

Please email Becky Straub, [email protected] if you have an SOP that other IGHID researchers could benefit from.

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Ten simple rules on how to write a standard operating procedure

Susanne hollmann.

1 Potsdam University, Potsdam, Germany

2 SB Science Management UG (haftungsbeschränkt), Berlin, Germany

Marcus Frohme

3 Technical University of Applied Sciences, Wildau, Germany

Christoph Endrullat

Andreas kremer.

4 ITTM Information Technology for Translational Medicine, Esch-sur-Alzette, Luxemburg

Domenica D’Elia

5 Institute for Biomedical Technologies, National Research Council, Bari, Italy

Babette Regierer

Alina nechyporenko.

6 Kharkiv National University of Radio Electronics, Kharkiv, Ukraine

Research publications and data nowadays should be publicly available on the internet and, theoretically, usable for everyone to develop further research, products, or services. The long-term accessibility of research data is, therefore, fundamental in the economy of the research production process. However, the availability of data is not sufficient by itself, but also their quality must be verifiable. Measures to ensure reuse and reproducibility need to include the entire research life cycle, from the experimental design to the generation of data, quality control, statistical analysis, interpretation, and validation of the results. Hence, high-quality records, particularly for providing a string of documents for the verifiable origin of data, are essential elements that can act as a certificate for potential users (customers). These records also improve the traceability and transparency of data and processes, therefore, improving the reliability of results. Standards for data acquisition, analysis, and documentation have been fostered in the last decade driven by grassroot initiatives of researchers and organizations such as the Research Data Alliance (RDA). Nevertheless, what is still largely missing in the life science academic research are agreed procedures for complex routine research workflows. Here, well-crafted documentation like standard operating procedures (SOPs) offer clear direction and instructions specifically designed to avoid deviations as an absolute necessity for reproducibility.

Therefore, this paper provides a standardized workflow that explains step by step how to write an SOP to be used as a starting point for appropriate research documentation.

Introduction

Nowadays, digital technologies are integral to how knowledge is produced and shared, and science is organized. Data availability is a critical feature for an efficient, progressive, and, ultimately, self-correcting scientific ecosystem that generates credible findings and has become a relevant element of scientific integrity [ 1 ]. However, the anticipated benefits of sharing are achieved only if data are of reliable quality and reusable [ 2 , 3 ]. Despite this need, it has been shown that fewer than one-third of (biomedical) papers can be reproduced in general [ 4 , 5 ]. Further studies showed that suboptimal data curation, unclear analysis specification, and reporting errors could impede reuse and analytic reproducibility, undermining the utility of data sharing and the credibility of scientific findings [ 6 – 9 ]. Standard operating procedures (SOPs) for industrial processes to achieve efficiency, quality, and uniformity of performance have existed since a long time ago. SOPs ensure that the user operates following consistent processes that meet best practice standards. Moreover, the use of SOPs ensures that processes are reviewed and updated regularly and that researchers inside and outside the same group or institute are enabled to reproduce or reuse results to enlarge the study or for other studies. Despite their importance, the need for the use of standards in life science research has emerged as crucial for the quality and reproducibility of research findings only in recent years [ 9 ]. The question of data quality and reproducibility poses new scientific and societal challenges for individual researchers, universities, scientific organizations, infrastructure facilities and funders, and the broader society [ 10 ]. The scientific community started to talk about a crisis of reproducibility and its dramatic impact on the economy and credibility of the research system [ 9 , 11 ] around 2016. Many community-driven initiatives such as the Research Data Alliance (RDA) [ 12 ] and the European Commission prompted a series of initiatives in support of the scientific community to cope with problems related to the need of new tools and strategies to improve the harmonization of standard initiatives [ 13 – 14 ] and the implementation of standards in the daily research work to improve research quality and data reuse. Since then, many steps forwards have been made in different fields of biological research [ 15 – 20 ].

There are recommendations providing guidelines for maintaining reproducible results by just applying simple rules. Those rules include the use of error annotations for produced data that are viable for evaluating the impact and credibility of single data associated with the generated results. Furthermore, it is essential to use annexes when research project results are published. Annexes aid the traceability of findings and the reproducibility of performed experiments and can be linked to the aforementioned error classifications. Input files, along with information of the applied software versions, perfectly fit into annexes and play a pivotal role for reproducing results. Finally, adopting these simple rules in the routine research practice within an SOP format aid the transparency of results and exert a decisive impact on scientific reproducibility [ 21 ]. Against this background, the implementation of a minimal quality assurance (QA) system as a systematic approach to review practices and procedures is inherent logical [ 22 ]. QA systems enable the users to identify possible improvements and errors and provide a mechanism for their use, for example, by developing and deploying a failure mode and effects analysis (FMEA) [ 23 ]. The basis of each quality system is a high-quality record providing a string of documents for the verifiable origin and quality of data. Also, the general documentation improves the traceability and transparency of research findings to prove the reliability of results. Such quality control systems should be based on and be in line with good laboratory practices (GLP), well-defined and validated protocols, and comprehensive SOPs [ 24 – 25 ]. The advantages of implementing SOPs in the daily workflow of academic researchers might not be immediately obvious and enlighten everyone. At first, it seems to be unnecessary and avoidable extra work. Indeed, without appropriate training, the setup of an SOP is time-consuming and does not appear to be a relevant asset. However, because each SOP describes one procedure only and not a series of complex procedures the efforts to be done remain feasible. For this reason, we provide you here with “10 Simple Rules on How To Write an SOP” that will enable you to produce a reliable and verifiable set of your research data.

The Ten Rules

Fig 1 demonstrates the workflow of SOP writing along the line from its preparation, validation, and approval to its implementation and follow-up processes, which will be detailed in the following 10 rules.

Workflow of SOP development, its implementation, and monitoring.

Rule 1: Knowing when to write an SOP

SOPs are always needed when critical processes or workflows need to be repeated in a reproducible way or when defined procedures are obliged by compliance guidelines. In other words, SOPs are vital instruments for maintaining consistent quality. Hence, every research institution which faces such processes, compliance requirements or has demand for quality should be encouraged to develop new or follow existing SOPs. Crosscheck within your institution for templates. There is no need to reinvent the wheel. Often templates are existing in your institution, but their existence might not be well communicated. Contact your data or quality manager for information. There also often exists a shared team server or cloud, containing all internal SOPs being accessible for each appropriate member or user, respectively. If your institute or department does not have official templates, ask other groups if they already have SOPs in use. If so, your colleagues should be happy to share their knowledge with you. If there is no template available, you have a pioneering role. In this case you can run a quick online search for SOP templates to be used as a starting point. It is wise to involve the technicians of your lab as well as the leader of your group or department and the quality manager and/or data manager of your institution. The initial step is now to draft a cover sheet and discuss the content of the SOP with the relevant stakeholders (reviewers and approvers) of your institution (Rules 3 and 6). Depending on the peculiarity of research you can choose an appropriate SOP format or develop your own. The resulting unique template can then be further used by all members of your group, department, or institution and by your wider community of practice.

Rule 2: Write the introduction: describe the purpose (the why)

An essential aspect of any SOP is introduction and purpose forming. The introduction section specifies the need and capability of the procedures for the research environment in which the process is being established. Identify the specific reason you decided to write your SOP. Which specific process do you address? Which specific procedures will be covered, and which are not covered? Clarifying what the specific focus of your document is will facilitate the use of your SOP by your colleagues. Richie Norton writes, “Simplicity is complex. It's never simple to keep things simple. Simple solutions require the most advanced thinking” [ 26 ]. The way you frame the information describing the process matters. Consider "less is more." Trying to tackle too much at once will mostly only lead to confusion. Represent the complex aspects of a process in a way to make it as simple as possible to make it also understandable even for users who are not from your field.

Rule 3: Set up the document structure

Every single SOP should consist of three sections:

The cover page

• The sequence of steps or tasks (metadata) for the given procedure (Rule 4)
• A list of references and definitions (Rule 5)

The cover page represents a control block used to house the document control information required to configure management and compliance standards.

It should contain the following information ( Fig 1 ):

• administrative information about the institution and/or department
• a title that clearly identifies the activity or procedure

The SOP’s cover page should provide information about traceability of the SOP, including information about the purpose and scope, its author, issuing, any changes made, and its status (draft, approved, revised, or removed).

• page number and total number of pages of the SOP
• the date of issue (or of versioning)
• possible safety instructions
• the names of individuals who prepared and approved the SOP
• the name of the reviewers, including the date of the review
• a description of the purpose and field of application
• the name and function of the author
• the name and function of the approver

There are standardized abbreviations to describe elements of the respective SOP on the cover page. Table 2 provides a list of typical abbreviations for an SOP category.

It is recommended to use a digital object identifier (DOI) for the identification of the SOP in accordance with ISO 26324:2012 [ 27 ].

Each following page should have a heading and/or footing note mentioning ( Table 3 )

All SOP pages should have an identifier referring to the cover page and consist of administrative information about the institution and/or department, the short title of the SOP, the page number out of the total number, the date, and approval and/or version number.

• short title of the SOP
• date of approval and/or version number

A version number can be assigned in accordance with semantic versioning [ 28 ] recommendations as guidelines used in source control systems like GitHub [ 29 ].

The presentation of dates, including date of issue, versioning, date of review, and approval should be in accordance with the format specified in ISO 8601 [ 30 ].

The final step in creating your SOP template should involve a note on the styles, fonts, and margins that you intend to use. You can download a full template SOP at Zenodo as a writable PDF [ 31 ].

Rule 4: Fill in the content

The procedure.

Start at page 2 to compile the metadata. In this step you describe the activities and the sequence of steps or tasks for the given procedure. Always consider the aim of the SOP; this will help you to focus on the specific procedure you describe. However, an SOP may contain multiple SOPs provided that each one is cited by number and full information is provided. Every user should be able to understand your work instructions. As George Orwell said, "Good [writing] is like a windowpane" [ 32 ]. Consider the knowledge and skills of potential users and the level of detail to present the process description. Long preambles should be avoided. Work instructions should follow a single style and follow a stepwise process strictly. Balance the level of detail, avoid unnecessary specification (e.g., “blue-cap tubes”) and alternatives; if alternatives are necessary, explain what dictates which action. Ensure consistency in terms of terminology, layout, media, and method and, as much as possible, avoid polysyllabic words, complex sentences, jargon, acronyms, or too many terms (without explaining them). To facilitate handling of the different data types and formats within the same workflow, the impact of such diversity to the usability of data and metadata should be minimized. Consider the different work cultures and different circumstances within people’s work and explain and describe the how and what to do. To optimize the structure of you SOP.

• break the process into sections
• break the sections into specific steps
• number the steps or add bullet points for clarity.

Describe each task in detail, including timeframes and tools required to complete assignments and achieve expected outcomes.

Rule 5: References and definitions: Specify tools required for the task

The workflow elements may involve different types of resources and tools. Depending on a particular task, the selection of tools can also comprise modeling and simulation tools, data repositories, and compiler construction tools. Do not forget to add relevant references. Reference materials can include normative documents, instructions, and standards as well as research papers, graphical material, photographs, and even different SOPs. Provide all definitions of terms and abbreviations that are to be used in the procedure. Harmonize and align with standard terminologies used within your field. These should be provided as an annex.

Rule 6: Set up responsibilities and nominate reviewers and approvers

Reviewers should be nominated and appointed responsible for each particular task. These persons should have appropriate scientific knowledge and expertise as well as experience in the field. Usually, the initial SOP-author(s) is/are responsible for monitoring and reviewing the SOP. They will ensure that the SOP reflects the tasks described in the document. Open discussion on controversial aspects related to the SOP should be allowed among reviewers to guarantee a proper revision. Changes to SOPs should preferably be made by the creator. Each change needs again to be reviewed and approved by the responsible persons and by an increase of the revision number (Rule 8). The team of reviewers should agree on a timeframe to monitor and align the current state-of-the-art SOP.

Rule 7: Test with a colleague: Perform training

Congratulations! By reaching this step you wrote your first SOP. Now it is time to check if the SOP is clear and understandable for all potential users. Hence ask a colleague (it can be a researcher or a technician) to read the SOP and, if feasible, execute a test run. Ask the test person to be constructive and critical and wait for his or her feedback or questions. Consider that the test person should be able to run the experiment without any support. Do not interfere while testing to receive authentic feedback and to avoid falsifying the result.

Once written, it is essential that all staff is appropriately trained with and familiarized in the use of the new SOP. This can easily be integrated within the annual safety instructions or as part of a running seminar series. Retraining should be conducted regularly but also when there is a change in SOPs. Ensure that showing attendance at training is documented.

Rule 8: Review and approve

Once your SOP is tested, make it available for the reviewers’ team for a final check. Once substantial comments are received, discuss them with your colleagues to ensure a successful outcome and that the SOP is clear for everybody. Include all relevant edits to improve the document. Repeat the procedure until the SOP is agreed by all stakeholders and, subsequently, send the document to the quality manager for approval afterwards. The final document should be sent to the assigned SOP approvers, who will sign it. In case an SOP is out of date due to the introduction of new technologies or changes in the organizational structure, the SOP should be terminated, labelled (out of date), and archived for traceability. The new and valid version should be distributed. All valid versions should be stored and accessible in a folder at a central location. By this, you ensure that valid and approved SOPs exist and every employee receives the information necessary for their work. To keep track of any deviations from existing SOPs, the establishment and deployment of an exception log might be a powerful instrument. This log should ideally entail a documentation of any deviation, the reason for the deviation, the outcome, any troubleshooting which has been applied, and resolutions and appropriate communication. Regarding the latter, issues or reasons for deviations as well as necessary changes or modifications in the SOP should be discussed with and signed by all involved stakeholders and supervisors, respectively [ 33 ].

Rule 9: Update document: Specify validation and periodic review date

Do not forget to review and update an SOP regularly to keep it up to date and useful for current and future use. Your SOP should be validated and reviewed periodically to improve the document and reflect any changes that have been made or are necessary. All changes should be entered into a revision form, which comprises version number, change data, reason and description for change, reviewers’ data, and signatures. The revised or updated document should be shared immediately with all respective users, while clarifying that the former SOP is outdated. The SOP compliance maintenance could be easily implemented by using an electronic lab notebook (ELN), which might keep track of all deviations automatically, dependent on software and functions.

In this case, ensure the interoperability of used formats to enable export of the data into other systems. Furthermore, regular mandatory user training should be set up for the most important SOPs to ensure compliance.

Rule 10: Publish

It's all very good to have work instructions, but what is their value if they are only available in your office when the users who need them are somewhere else? The people performing the work should have easy access to the work instructions anytime and anywhere, most easily accomplished by setting up a secured team server or cloud on which all latest versions are uploaded. To add value to your SOP, make it available to a broad user community you should upload your SOP also in open access public repositories such as Zenodo [ 34 ], SEEK [ 18 ], OpenAIRE [ 35 ], FAIRsharing [ 36 – 37 ], or another.

Nowadays digital technologies and advanced computational methods are an integral part of daily laboratory practice. To best manage the generated data and avoid reproducibility issues, scientists need to implement FAIR data principles, suitable DMPs, and appropriate documentation. The lack of reproducibility within laboratory research discourages successful implementation of the wide-spread adoption of research results in the scientific community. One way to improve it is to provide consistency and traceability of existing standards and laboratory practices that are achievable with precise and clearly written SOPs.

Acknowledgments

This publication is based upon work from COST Action CHARME CA15110 [ 14 ] supported by COST (European Cooperation in Science and Technology). www.cost.eu .

Funding Statement

This work has been funded by COST (European Cooperation in Science and Technology) CA15110. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Standard Operating Procedures for Clinical Trials (SOPs)

The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. DGHI is pleased to share these documents with others who are working in resource-limited locations. Although most of these SOPs were developed for AIDS clinical trials, many of these documents can be modified and extrapolated to meet your specific project needs.

SOPs are available in the areas of:

Administrative   ( Download PDF Bundle - 93KB Zip File )

• Procurement
• Vehicle use

Clinical   ( Download PDF Bundle - 1.6MB Zip File )

• Clinic Flow policies & procedures
• Clinical research management plan
• Protocol implementation
• Source documentation
• Essential documents
• Office charts
• Study visits and missed visits
• Study medications
• Toxicity management
• Subject recruitment
• Subject logs and codes
• Transportation reimbursement
• Ethics committee submission checklist
• New protocol evaluation survey
• Orientation manual
• Quality management plan
• Research coordinator checklist
• Study nurse checklist
• Monitoring visits
• Regulatory affairs
• Site assessment
• Site responsibility
• Patient and study identification numbers
• Safety reports
• Training record
• Venipuncture

Data Management  ( Download PDF Bundle - 92KB Zip File )

• Case report forms (CRF) completion
• CRF scanning
• Data security
• Definitions
• International communications
• Query resolution
• Power failure during data entry
• CRF quality assurance
• Table of contents

Laboratory  ( Download PDF Bundle - 2.9MB Zip File )

• Over 60 SOPs regarding laboratory equipment, supplies, and tests

Pharmacy  ( Download PDF Bundle - 316KB Zip File )

• Infant prescriptions
• Pharmacy plan
• Study accountability records
• Post trial ARV access
• Refrigerator temperature logs
• Room temperature logs
• Site pharmacist checklist
• Policies and Procedures
• Disposal of unfit pharmaceuticals
• Disposal of unfit products
• Importing study products
• Prescription numbering
• Drug transfer form

SOPs, Policies and Guidelines

Institutional policies and procedures.

• Research Support Offices
• Occupational and Environmental Safety Office  (OESO)
• Financial Services
• Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel 
• CRU Policy Non-Industry Grant Proposals
• Waiver of A/RPM Effort on Grant Proposals

UNMC Center for Clinical & Translational Research

Standard Operating Procedures

•   Clinical Research Spotlight Award
•   Clinical Research Development Fund
•   Clinical Recruiting Resources
•   Biostatistics
•   Clinical Research Center (CRC)
•   Utilizing CRC Clinical Services
•   Clinical Research Units
•   Study Intake
•   Study Monitoring
•   Site Information Sheet
•   Clinical Research Services
•   Standard Operating Procedures
•   Clinical Research Education
•   Fees
•   Contact Us
•   Electronic Health Record Data Access Core
•   Research Pharmacy
•   Sponsored Programs Administration
•   Biomedical Informatics
•   Disease Specific Biobanks & Registries
•   Nebraska Biobank
•   Research Policies
•   Uploading Radiologic Images for Research Studies
•   Pathology Samples for Clinical Research
•   UNeHealth Guidebook

Clinical Research Center Standard Operating Procedures

Below are the Standard Operating Procedures of the Clinical Research Center. They are categorized into 4 sections, Study Management, Clinical Operations, Administrative, and Emergency Preparedness. You may edit and adapt for your department.

Study Management

• SM01- Assessing Protocol Feasibility
• SM02- Site Qualification Visit
• SM03- Study Intake Process
• SM11- Regulatory Binder
• SM12- Management of Regulatory Documents- eReg
• SM13- Management of Regulatory Documents
• SM14- IRB Approval
• SM15- Staff Protocol Training
• SM16- DOA Log Combinded
• SM17- Site Initiation Visit
• SM31- Recruitment of Subjects
• SM34- Informed Consent
• SM35- General Correspondence
• SM36- Protocol Amendments
• SM37- Release of Information - Monitoring
• SM38- Audits and Inspections
• SM39- Case Report Forms
• SM40- Redacting Source Documents
• SM41- Certified Copies of EMR
• SM42- Adverse Events
• SM44- Review of Laboratory Results
• SM45- Home Health
• SM51- Closeout (Termination) Visit
• SM52- Insufficient Accrual

Clinical Operations

• CO01- Staff Competencies
• CO02- CRC Laboratory Orientation
• CO03- Laboratory Orientation
• CO04- Performing an ECG
• CO05- Monoclonal Antibody Admisitration
• CO21- Equipment Calibration and Maintenance
• CO22- Eyewash Maintenance
• CO31- Using CRC Space
• CO32- High Containment Space Utilization
• CO33- Scheduling Visits
• CO34- Offsite Work Activities
• CO41- Kit Destruction
• CO42- Allergy Hypersensitivity Management
• CO43- Medication Storage
• CO50- Infection Control
• CO51- Removing Paper Consent from COVID+ Room
• CO52- COVID Equipment Removal

Administrative

• AD01- Staff Orientation and Training
• AD02- Dress Code
• AD03- Attendance and Leave Requests
• AD05- Key Control
• AD06- Guidelines for Effective Remote Working
• AD07- Travel
• AD08- Professional Development
• AD21- Development and Review of Policies and SOP's
• AD22- Educational Grants from Sponsors

Emergency Preparedness

• EP01- Medical Emergency (Code Blue)
• EP02- Hazardous Materials
• EP03- Power Outage
• EP04- Essential Staffing
• EP05- External Disaster
• EP07- Severe Weather
• Opted-In Subject Recruitment Policy (CRC-SOP-51)
• Recruitment Request Form (Attachment B: Fillable PDF)

Access the UNMC Policies & Procedures Wiki

Writing Standard Operating Procedures (SOPS)

Standard operating procedures (sops) are standardized written procedures, with detailed instructions to record routine operations, processes and procedures followed within a business organization..

In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc...) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidance. SOPs should contain enough detail to guide research staff through a particular procedure and thereby establish uniformity in the everyday functions of the department. The SOP should have a specific aim but be written in a general format to allow for easy implementation across a broad set of venues and circumstances. The SOP however, should contain specifically defined procedures that can be followed without deviation.

All SOPs for the department should be written in the same format with consistent font size, unit title, and section headers. It should include page numbers, date of initial approval, date it was effective within the department and date of revision if applicable. The body of the SOP at a minimum should include the objective of the SOP, definition of key terms and acronyms, defined list of responsible individuals and details outlining the procedures with attachments of examples if applicable. It is important to reference applicable guidance and regulations within the SOP, such as ICH E6 Good Clinical Practice and 21 CFR 50. The SOP should also include the signature of the Administrator or Director of the group with the date of approval. Existing SOPs should be reviewed at regular intervals to reassess applicability of the policy. Annual review is recommended and review prior to sponsor interactions is encouraged.

Distribution, education, and training on new departmental SOPs should be consistent. In-service training and Computer Based Learning modules (CBLs) are typical methods that can be used to educate and train staff on SOPs. It is important to document the date responsible research staff has been appropriately trained and agree to comply with new SOPs that are implemented by the department. Research staff should be monitored consistently to ensure compliance and receive refresher training at regular intervals.

Common SOPs

• GCP Training
• Authority and Delegations of Responsibilities of Research Staff
• Subject Screening and Recruitment
• Informed Consent Process and Documentation
• Eligibility Confirmation
• Source Documentation
• Data Management
• Protocol Deviations
• Adverse Events and Serious Adverse Events Reporting
• Confidentiality of Information
• Drug/Device Storage, Accountability, and Management
• Regulatory Document Submission Process (Initial Submissions, Amendments and Continuing Reviews)
• Sample Processing and Shipping Training
• Monitoring Visits
• Sponsor, CRO and Internal Audits
• Writing SOPs
• Record Organization and Retention
• Sub-Site Management

See also  Standard Operating Procedure for Good Clinical Practice .

If you have a disability and experience difficulty accessing this content, please submit an email to [email protected] for assistance.

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• IACUC Approval Timeline
• Research with Human Subjects (IRB) Overview
• Approval Timelines & IRB Process
• Meeting Dates, Deadlines & Reviewers

Clinical Research Standard Operating Procedures

List of Standard Operating Procedures

• SOP #101- Writing SOPs
• SOP #102 - Training Personnel
• SOP #103 - Responsibilities of Research Team
• SOP #104 - Conduct of Clinical Study
• SOP #105 - Document Control
• SOP #201 - Regulatory Documentation  (regulatory binder)
• SOP #202 - Privacy and Confidentiality
• SOP #203 - IRB Submission
• SOP #204 - Adverse Event Reporting
• SOP #205 - Conflicts of Interest
• SOP #301 - Study Feasibility
• SOP #302 - Site Qualification visit
• SOP #303 - Site Initiation visit
• SOP #304 - Communication Practices
• SOP #305 - Investigational Product Accountability
• SOP #306 - Randomization and Blinding
• SOP #307 - Venipuncture
• SOP #308 - Specimens Collection and Management
• SOP #309 - Preparing Injectable Medications
• SOP #310 - Site Monitoring Visit
• SOP #311 - Site Closeout Visit
• SOP #312 - Protocol Compliance
• SOP # 401 - Subject Recruitment
• SOP #402 - Informed Consent
• SOP #403 - Eligibility and Enrollment
• SOP #404 - Protecting Confidentiality of Study Subjects
• SOP #405 - Study Visits
• SOP #406 - Payments to Subjects
• SOP #501 - Case Report Forms
• SOP #502 - Source Documentation
• SOP #503 - Electronic Records
• SOP #504 - Archiving Study Records
• SOP #505 - Printing and Certifying Medical Records
• SOP #601 - Quality Control 
• SOP #602 - FDA Audits
• SOP #603 - Corrective and Preventative Action Plan
• SOP #604 - Equipment Maintenance and Calibration
• SOP #605 - Temperature Monitoring
• Source Documentation Checklist
• Research Involving Animals (IACUC)
• Research with Human Subjects (IRB)

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