GCP 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

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   - Updated Jun 2023

       SOP Template - Updated Jun 2023

2.  Study Team Training and Education - Updated Jun 2023

        Training Log - Updated Jun 2023

3.  Responsibilities of the  Research Team- Updated Jun 2023

        Study Responsibility Log - Updated Jun 2023

4.  Feasibility Assessment - Updated Jun 2023

        Feasibility Questionnaire - Updated Jun 2023

5.  Study Initiation - Updated Jun 2023

        Regulatory Binder Table of Contents Template

        Study Responsibility Log - Updated Jun 2023

Case Report Form Templates (sample data collection forms, note to file sample language, regulatory binder document templates) 

6.  Communicating with CPHS - Updated Jun 2023

7. Clinical Research Records Retention - Updated Jun 2023

      Digital Storage of Clinical Research Documents -Updated Jun 2023

      Certification Template - Updated Jun 2023

8.  Drug Accountability  - Updated Jun 2023

        Drug Accountability Log - Updated Jun 2023

9.  Device Accountability - Updated Jun 2023

        Device Accountability Log - Updated Jun 2023

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

      Remote Consent and Electronic Consent Signature - Updated Jun 2023

14. Consent Document

        Consent Template

        Consent Elements

        Consent Document LAR

15. Subject Recruitment

       Subject Screening and  Enrollment Log

        Subject ID Linking 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 

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