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:
- Guidance documents
- Standard Operating Procedures
- 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 [email protected].
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
11. Study Completion Activities
FDA Inspection Checklist
FDA Inspection Information
13. Consent Process
Remote Consent and Electronic Consent Signature- Updated Apr 2025
Instructions - Setting up Consents Using Part 11 Compliant DocuSign
Instructions - Setting up Consents Using REDCap
14. Consent Document
Subject Screening and Enrollment Log
17. Unanticipated Problems Involving Risks to Subjects or Others
19. Source Documents
Sharing Source Documents for Remote Monitoring
20. Study Closure
21. Glossary
Other Resources:
External Links:
FDA Regulations Relating to GCP and Clinical Trials
Additional resources
- Committee for the Protection of Human Subjects
- Animal research
- Environmental health & safety
- Clinical research unit
- Center for Clinical and Translational Science
- Biostatistics, epidemiology and research design
- Core laboratories
- Sponsored projects
- Technology management
- Office of research
7000 Fannin Street, Suite 795
Houston, Texas 77030
phone: 713-500-3622
fax: 713-500-0334
[email protected]