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§ 312.56 Review of ongoing investigations.
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(d) A sponsor who determines that its investigational drug presents an unreasonable and significant ris… +
§ 312.57 Recordkeeping and record retention.
(a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the … +
§ 312.57 recordkeeping and record retention.
(a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the… +
§ 312.58 Inspection of sponsor's records and reports.
(a) FDA inspection. A sponsor shall upon request from any properly authorized officer or employ… +
§ 312.60 General responsibilities of investigators.
An investigator is responsible for ensuring that an investigation is conducted according to the si… +
§ 312.60 General responsibilities of investigators.
An investigator is responsible for ensuring that an investigation is conducted according to the s… +
§ 312.61 Control of the investigational drug.
An investigator shall administer the drug only to subjects under the investigator's personal supervision… +
§ 312.62 Investigator recordkeeping and record retention.
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(c) Record retention. An investigator shall retain records required to be maintained u… +
§ 312.62 Investigator recordkeeping and record retention.
(a) Disposition of drug. An investigator is required to maintain adequate records of the di… +
§ 312.62 Investigator recordkeeping and record retention.
(a) Disposition of drug. An investigator is required to maintain adequate records of the di… +
§ 312.62 Investigator recordkeeping and record retention.
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(b) Case histories. An investigator is required to prepare and maintain adequate and a… +
§ 312.64 Investigator reports.
(a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for coll… +
§ 312.64 Investigator reports.
(a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for coll… +
§ 312.64 Investigator reports.
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(c) Final report. An investigator shall provide the sponsor with an adequate report shortly after completion of … +
§ 312.64 Investigator reports.
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(b) Safety reports. An investigator must immediately report to the sponsor any serious adverse event, whether or … +
§ 312.68 Inspection of investigator's records and reports.
An investigator shall upon request from any properly authorized officer or employee of FDA,… +
§ 312.69 Handling of controlled substances.
If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequ… +
§ 312.70 Disqualification of a clinical investigator.
[…]… +
§ 312.85 Phase 4 studies.
Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (phase 4) studi… +
§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a dru… +
