GCP Guidance Policies and Templates

policies

A group of senior research nurses and research coordinators are working to develop standard operating procedures for clinical trial management and conduct according to the Good Clinical Practice guidelines. The documents shared on this page have been developed by this group. The documents included are: 

  1. Guidance documents
  2. Standard Operating Procedures
  3. Research Tools - templates, logs, checklists, worksheets, flowsheets

These documents are not meant to be prescriptive. The best way to use them would be to download them and edit them to suit your own study team's work flow. 

If you would like to join this work group or if you have questions, comments and suggestions please contact us at clinicaltrials@uth.tmc.edu.

1. Developing and Maintaining Standard Operating Procedures  NEW

       SOP Template NEW

2.  Study Team Training and Education NEW

        Training Log

3.  Responsibilities of the  Research Team

        Study Responsibility Log

4.  Feasibility Assessment

        Feasibility Questionnaire

5.  Study Initiation

        Regulatory Binder Table of Contents Template

        Study Responsibility Log

Case Report Form Templates (sample data collection forms) 

6.  Communicating with CPHS

        CPHS Communication Log

7.  Records Retention

8.  Drug Accountability

        Drug Accountability Log

Patient Returns Chain of Custody Form - MHH IDS 

9.  Device Accountability

        Device Accountability Log

10. Quality Management Plan

        Chart Review Checklist

        Monitoring Checklist

        Monitoring Log

11. Study Completion Activities

        Study Closure Checklist

12. Preparing for Inspections

        FDA Inspection Checklist

        FDA Inspection Reporting

        FDA Inspection Information

13. Consent Process

14. Consent Document

        Consent Template

        Consent Elements

        Consent Document LAR

15. Subject Recruitment

        Flyer Template

        Subject Screening and  Enrollment Log

        Subject Visit Schedule Log

        Subject Contact List

16. Specimen Collection

        Specimen Log

17. Unanticipated Problems Involving Risks to Subjects or Others

        UP Tracking Log

18. Protocol Deviation

        Protocol Deviation Log

19. Source Documents

        Study Worksheet / Flowsheet

20. Study Closure

        Study Closure Checklist

21.   Glossary                  

        Commonly Used Acronyms


Other Resources:

IND/IDE Policies

Quality Management Plans

External Links:

FDA Regulations Relating to GCP and Clinical Trials

ICH GCP Guidelines

ADDITIONAL RESOURCES

CLINICAL RESEARCH UNITS (CRU) | BERD | REDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS | ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH 

Center for Clinical and Translational Sciences

Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795

Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu