 |
Code of Federal Regulations (Last Updated: November 8, 2024) |
 |
Title 21 - Food and Drugs |
|
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
|
SubChapter D - Drugs for Human Use |
|
|
Part 312 - Investigational New Drug Application |
|
|
Subpart D - Responsibilities of Sponsors and Investigators |
| § 312.50 - General responsibilities of sponsors. |
| § 312.52 - Transfer of obligations to a contract research organization. |
| § 312.53 - Selecting investigators and monitors. |
| § 312.54 - Emergency research under § 50.24 of this chapter. |
| § 312.55 - Informing investigators. |
| § 312.56 - Review of ongoing investigations. |
| § 312.57 - Recordkeeping and record retention. |
| § 312.58 - Inspection of sponsor's records and reports. |
| § 312.59 - Disposition of unused supply of investigational drug. |
| § 312.60 - General responsibilities of investigators. |
| § 312.61 - Control of the investigational drug. |
| § 312.62 - Investigator recordkeeping and record retention. |
| § 312.64 - Investigator reports. |
| § 312.66 - Assurance of IRB review. |
| § 312.68 - Inspection of investigator's records and reports. |
| § 312.69 - Handling of controlled substances. |
| § 312.70 - Disqualification of a clinical investigator. |