| Revision Date | ||
| Exempt New Study Application Checklist | 10/17/2008 | |
| Expedited New Study Application Checklist | 10/17/2008 | |
| Full Committee New Study Application Checklist | 10/17/2008 | |
| Humanitarian Use Device Checklist | 10/13/2008 | |
| Human Biospecimen Repository Checklist | 10/13/2008 | |
| Data Repository Checklist | 10/13/2008 | |
| Emergency Use Checklist | 10/14/2008 | |
| Revision Date | ||
| Exempt Application | 12/19/2008 | |
| Expedited Application | 05/20/2008 | |
| Full Committee Application | 05/20/2008 | |
| Facilitated Application | 05/19/2009 | |
| Humanitarian Use Device Application | 04/28/2008 | |
| Human Biospecimen Repository Application | 03/20/2006 | |
| Data Repository Application | 05/04/2006 | |
| Emergency Use Application | 04/02/2009 | |
|
Protocol Document Guidelines |
03/11/2008 |
| Revision Date | ||
| Department Review Form | 03/13/2006 | |
| Continuation or New Study Sponsorship Information Form | 10/16/2009 ~ new process; see fee page | |
| 1. Additional Investigator List | 02/04/2009 | |
| 2. Studies Involving Minors | 05/14/2009 | |
| 3. Studies Involving drugs, biologics, radiopharmaceuticals | 02/04/2009 | |
| 4. Studies Involving Biological Specimens | 04/202009 | |
| 5. Studies Involving Exposure to Ionizing Radiation | 11/06-2008 | |
| 6. Data and Safety Monitoring | 11/06/2008 | |
| 7. Not currently in use | ||
| 8. Request for Waiver of Informed Consent | 11/06/2008 | |
| 9. Studies Involving Use of Medical Devices | 11/10/2008 | |
| 10. Studies Involving Prisoners | 11/10/2008 | |
| 11. Studies Involving use of PCIR (formerly GCRC) | 10/28/2009 |
| Revision Date | ||
| Understanding COI Forms | 03/26/2009 | |
| Conflict of Interest form - UNM Employee or Student | 02/02/2009 | |
| Conflict of Interest form - Non-UNM Personnel | 03/26/2009 | |
| Conflict of Interest Website - http://hsc.unm.edu/research/coi/ |
| Revision Date | ||
| UNMHSC Consent Form | 08/05/2009 | |
| Minors Assent Form | 8/05/2005 | |
| Tissue Bank Consent Form | 03/05/2007 | |
| VA Consent Form | 10/21/2008 | |
| Survey Research Consent Form | 02/13/2007 | |
| Combined Consent/HIPAA (minimal risk/non-treatment study) | 11/05/2007 | |
| Contact for Future Research Consent Form | 04/27/2007 | |
| Parent of Minor Student Survey Consent Form | 08/31/2005 | |
| Blood Draw Consent Form | 11/27/2007 | |
| Example Study Schedule Calendar for Participant | 12/18/2006 | |
| Spanish Versions | ||
| UNMHSC Spanish Version Consent Form | 11/11/2009 | |
| Spanish Minor Assent Form | 7/23/2009 | |
| Spanish Tissue Bank Consent Form | 9/21/2009 | |
| Spanish Survey Research Consent Form | 7/21/2009 | |
| Spanish Combined Consent/HIPAA (minimal risk/non-treatment) | 8/10/2009 | |
| Spanish Contact for Future Research Consent Form | 8/3/2009 | |
| Spanish Parent of Minor Student Survey Consent Form | 8/4/2009 | |
| Spanish Blood Draw Consent Form | 8/4/2009 | |
| Spanish Example Study Schedule Calendar for Participant | 8/10/2009 | |
| Spanish Version Short Consent Form | 8/4/2009 |
| Revision Date | ||
| Continuation (Progress) Report | 03/09/2009 | |
| Closure of Research | 06/08/2009 | |
| Reactivation of Research | 01/18/2008 | |
| Change Request form (Minor change: administrative changes) | 10/16/2009 | |
| Amendment Request Form (Major change: change of PI; change in study design, etc) | 10/20/2009 | |
| Change/Addition of Investigator Amendment Form | 10/16/2009 | |
| Humanitarian Use Device Continuation or Closure | 12/05/2006 | |
| Tissue or Data Repository Continuation or Closure | 02/05/2007 | |
| Continuation Sponsorship Fee Form | 10/16/2009 | |
| Amendment Sponsorship Fee Form | 10/16/2009 | |
| Problems or events that meet all three criteria below must be reported to the HRRC on an Event Form: | ||
|
1. Unanticipated 2. Caused Harm or Increase of Risk 3. Is more likely than not related to the research |
||
| Other events including
protocol violations, incorrect consent procedures, etc. may
also be reportable to the HRRC. |
||
| Please
see
HRRC manual Section 8.2
for more information including a list of specific events that are reportable to the HRRC. |
||
|
Events must be reported to HRRC as soon as possible, but no
later than 5 days from the event date or "site awareness date". |
||
| If you have any questions about reporting events, please contact HRRC at 272-1129 | ||
| Revision Date | ||
| Event Form | 10/14/2008 | |
| The following tracking log is for Investigators to maintain in their records. | ||
| Tracking log for Non-reportable Events | 08/24/2009 | |
| Memo to sponsors re: do not submit tracking log to HRRC | 07/10/2008 | |
| Revision Date | ||
| UNM HIPAA Authorization Addendum | 04/04/2006 | |
| UNM HIPAA Authorization - Spanish Version | 10/16/2008 | |
| VA HIPAA Authorization Addendum | 11/10/2009 | |
| HIPAA Authorization Waiver Request (Attachment 8) | 10/19/2008 | |
| 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 HRPO front desk at 505-272-1129. Attached are many tools that may assist the investigator to conduct, document, or track their research: |
||
| 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 | ||
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