Current GCRC Forms by Category
Initial Application
| Revision Date | ||
| Overview of the GCRC Application Process | 10/28/2009 | |
| GCRC Application | 10/28/2009 | |
| DSMP-Instructions | 08/24/2006 | |
| GCRC DSMP(data safety monitoring plan) | 08/01/2008 | |
| DSMP Risk Classification list | 08/24/2006 | |
| GCRC Initial Submission Checklist | 10/28/2009 | |
| ISM COI Disclosure form | 08/13/2008 | |
| DSMB Charter Template | 05/07/2009 | |
| Initial Application Contacts | 09/17/2009 | |
| CTSC Study Budget Worksheet | 11/13/2008 | |
| Protocol Guidelines | ||
Continuing Review
| Revision Date | ||
| Independent Monitor Report Template | 08/13/2008 | |
Addendums
| Revision Date | ||
| GCRC Addendum Request | 08/07/2009 | |
Additional Resources
| Revision Date | ||
| HRRC Web Page with associated forms | ||
New BRIDGES Program Information and Forms
| The BRIDGES (Begin Research Initially with Directed Guidance through Education and Support) Program was developed specifically to facilitate Good Clinical Practices (GCP)
in investigator initiated research. The purpose is to create an organized system for record management setting the research up for collection of high quality and credible
results.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for conducting research. GCP standards are generally a requirement for pharmaceutical and federal cooperative group research, however, many of the standards can be applied to investigator initiated research as well. Filing essential research documents and organization of records at a study site can be beneficial at several levels including: - Production of "clean" data, increasing likelihood of credible, valid results - Protection of subjects, the investigator, and the institution - Facilitation of the amendment and re-approval process - Keeping your research documents "audit ready" for any regulatory reviews For an initial BRIDGES consultation to discuss preparation of forms and documentation management, please email or call the Cheryl Reich at 505-272-6817. Attached are many tools that may assist the investigator to conduct, document, or track their research: |
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| 1. Tracking Log for Non-Reportable Events | ||
| 2. HRRC Event Form | ||
| 3. Tracking Log for Reporting | ||
| 4. Subject Enrollment Log | ||
| 5. Tracking Log of Patient Consent-Reconsent | ||
| 6. Log of IRB-Approved Documents | ||
| 7. Log of Documents Submissions | ||
| 8. Sample Order Form | ||
| 9. Sample Data Collection Form | ||
| 10. Accountability Record | ||
| 11. Lab Specimen Storage Log | ||
| 12. Temperature Log | ||
| 13. History and Physical-Neuro Exam | ||
| 14. Regulatory Binder Checklist | ||
| 15. Study Calendar | ||
| 16. Subject Demographic Form | ||
| 17. Concomitant Medications List | ||
| 18. Randomization Table | ||
| 19. Participant Compensation Log | ||
| 20. Participant Diary | ||
| 21. Checklist for Informed Consent Process | ||