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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 tania_hossain@med.unc.edu to request access. Pharmacy and laboratory SOPs are not included. For laboratory processes, please contact the UNC Global CTU Laboratory Manager, Amy James at amy_james@med.unc.edu

SOP Development

Laboratory research setting in Africa.

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

    These tools are referenced through the SOPs. Each folder contains templates for quality control, quality assurance, study visit data collection, excel calculators for grading, and other tools that have been developed over the years to reduce human error and redundancy in work along with increasing efficiency.

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

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    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.

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    Do you have an SOP to share with IGHID?

    Please email Becky Straub, bstraub@med.unc.edu if you have an SOP that other IGHID researchers could benefit from.

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