All Policies
- 100 Quality Management System Policy
- 101 Good Documentation Practices Policy
- 102 Audit Policy
- 103 Training Policy
- 104 Corrective and Preventive Action Policy
- 105 Quality System Requirements for Vendors Manufacturing Investigational Product Policy
- 201 Qualified Medical Expertise Policy
- 202 Protocol Development Policy
- 203 Clinical Trial Records Policy
- 204 Investigator's Responsibility Policy
- 205 Clinical Site Monitoring Policy
- 206 Clinical Site Activation Policy
- 207 Continuity of Operations Policy
- 208 Multicenter Clinical Trial Policy
- 301 Serious Adverse Events Reporting Policy
- 302 Implementing Sponsor-Initiated Temporary Clinical Holds Policy
- 303 Interim Analysis Reporting Policy
- 305 Sponsor Determination of Expectedness Policy
- 306 Independent Data and Safety Oversight Policy
- 401 Conflict of Interest Policy
- 402 Regulatory Compliance & File Management Policy
- 403 Oversight by Institutional Review Board Policy
- 404 Manufacturer Expanded Access Policy
- 405 Posting to ClinicalTrials.gov Policy
- 406 Selection of IND or IDE Regulatory Filing Policy
- 407 Communications with the FDA Policy
- 408 Determining When to Prepare an Investigator's Brochure Policy
- 409 Single Patient Expanded Access Policy
- 410 Final Clinical Study Reports for Studies under CCR-held INDs or IDEs Policy
- 411 Emergency Exceptional Release of Product Policy
- 412 Responding to FDA Clinical Holds Policy
- 501 Investigational Product Management Policy
- 502 Investigational Product Stability Studies Policy
- 503 Oversight of Investigational Product Shipments Policy
- 504 Temperature Excursions of Investigational Product During Storage and Shipping Policy
Policy Updates
| Quarter | Date | Change | Policy |
|---|---|---|---|
| 2024 Q3 | 07/22/24 | New Policy | 504 Temperature Excursions of Investigational Product During Storage and Shipping Policy |
| 07/22/24 | New Policy | 501 Investigational Product Management Policy | |
| 2024 Q2 | 06/14/24 | Revision | 411 Emergency Exceptional Release of Product Policy |
| 2024 Q1 | 03/27/24 | Revision | 207 Continuity of Operations Policy |
| 03/27/24 | Revision | 202 Protocol Development Policy | |
| 03/21/24 | Revision | 204 Investigator's Responsibility Policy | |
| 03/21/24 | Revision | 201 Qualified Medical Expertise Policy | |
| 03/12/24 | Revision | 306 Independent Data and Safety Oversight Policy | |
| 03/06/24 | Revision | 301 Serious Adverse Events Reporting Policy | |
| 02/13/24 | Revision | 206 Clinical Site Activation Policy | |
| 01/31/24 | Revision | 402 Regulatory Compliance & File Management Policy | |
| 01/31/24 | Revision | 403 Oversight by Institutional Review Board Policy | |
| 01/31/24 | Revision | 404 Manufacturer Expanded Access Policy | |
| 01/31/24 | Revision | 407 Communications with the FDA Policy | |
| 01/31/24 | Revision | 408 Determining When to Prepare an Investigator's Brochure Policy | |
| 01/24/24 | Revision | 203 Clinical Trial Records Policy | |
| 01/24/24 | Revision | 401 Conflict of Interest Policy | |
| 01/10/24 | Revision | 410 Final Clinical Study Reports for Studies under CCR-held INDs or IDEs Policy | |
| 01/05/24 | Revision | 104 Corrective and Preventive Action Policy | |
| 01/05/24 | Revision | 103 Training Policy | |
| 01/05/24 | Revision | 102 Audit Policy | |
| 01/05/24 | Revision | 101 Good Documentation Practices Policy | |
| 2023 Q4 | 11/08/23 | New Policy | 503 Oversight of Investigational Product Shipments Policy |
| 11/08/23 | New Policy | 502 Investigational Product Stability Studies Policy | |
| 2023 Q3 | 09/18/23 | Revision | 303 Interim Analysis Reporting Policy |
| 09/08/23 | New Policy | 412 Responding to FDA Clinical Holds Policy | |
| 09/06/23 | New Policy | 302 Implementing Sponsor-Initiated Temporary Clinical Holds Policy | |
| 08/01/23 | Revision | 405 Posting to ClinicalTrials.gov Policy | |
| 07/26/23 | Revision | 100 Quality Management System Policy | |
| 07/25/23 | New Policy | 305 Sponsor Determination of Expectedness Policy | |
| 2023 Q2 | 05/04/23 | Revision | 105 Quality System Requirements for Vendors Manufacturing Investigational Product Policy |
| 2023 Q1 | 03/31/23 | Revision | 203 Clinical Trial Records Policy |
| 03/16/23 | Revision | 406 Selection of IND or IDE Regulatory Filing Policy | |
| 01/30/23 | Revision | 206 Clinical Site Activation Policy | |
| 2022 Q4 | 12/30/22 | Revision | 203 Clinical Trial Records Policy |
12/19/22 | Revision | 306 Independent Data and Safety Oversight Policy | |
11/17/22 | Revision | 409 Single Patient Expanded Access Policy | |
11/16/22 | Revision | 301 Serious Adverse Events Reporting Policy | |
11/14/22 | Revision | 208 Multicenter Clinical Trial Policy | |
11/04/22 | Revision | 205 Clinical Site Monitoring Policy |
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