All Policies

Policy Updates

QuarterDateChangePolicy
2024 Q307/22/24New Policy504 Temperature Excursions of Investigational Product During Storage and Shipping Policy
07/22/24New Policy501 Investigational Product Management Policy
2024 Q206/14/24Revision411 Emergency Exceptional Release of Product Policy
2024 Q103/27/24Revision207 Continuity of Operations Policy
03/27/24Revision202 Protocol Development Policy
03/21/24Revision204 Investigator's Responsibility Policy
03/21/24Revision201 Qualified Medical Expertise Policy
03/12/24Revision306 Independent Data and Safety Oversight Policy
03/06/24Revision301 Serious Adverse Events Reporting Policy
02/13/24Revision206 Clinical Site Activation Policy
01/31/24Revision402 Regulatory Compliance & File Management Policy
01/31/24Revision403 Oversight by Institutional Review Board Policy
01/31/24Revision404 Manufacturer Expanded Access Policy
01/31/24Revision407 Communications with the FDA Policy
01/31/24Revision408 Determining When to Prepare an Investigator's Brochure Policy
01/24/24Revision203 Clinical Trial Records Policy
01/24/24Revision401 Conflict of Interest Policy
01/10/24Revision410 Final Clinical Study Reports for Studies under CCR-held INDs or IDEs Policy
01/05/24Revision104 Corrective and Preventive Action Policy
01/05/24Revision103 Training Policy
01/05/24Revision102 Audit Policy
01/05/24Revision101 Good Documentation Practices Policy
2023 Q411/08/23New Policy503 Oversight of Investigational Product Shipments Policy
11/08/23New Policy502 Investigational Product Stability Studies Policy
2023 Q309/18/23Revision303 Interim Analysis Reporting Policy
09/08/23New Policy412 Responding to FDA Clinical Holds Policy
09/06/23New Policy302 Implementing Sponsor-Initiated Temporary Clinical Holds Policy
08/01/23Revision405 Posting to ClinicalTrials.gov Policy
07/26/23Revision100 Quality Management System Policy
07/25/23New Policy305 Sponsor Determination of Expectedness Policy
2023 Q205/04/23Revision105 Quality System Requirements for Vendors Manufacturing Investigational Product Policy
2023 Q103/31/23Revision203 Clinical Trial Records Policy
03/16/23Revision406 Selection of IND or IDE Regulatory Filing Policy
01/30/23Revision

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


Last updated by Hestick, Jody (NIH/NCI) [E] on Jul 25, 2024