Sponsor-Investigators are responsible for the following obligations as set forth under 21 CFR Part 312 – Investigational new drug application, Subpart D – Responsibilities of Sponsors and Investigators.
312.50: General responsibilities of sponsors
Ensuring proper monitoring of the investigation.
Ensuring the investigation is conducted in accordance with the protocol.
Maintaining an effective IND with respect to the investigation.
Ensuring the FDA is promptly informed of significant adverse effects or risks with respect to the drug.
312.52: Transfer of obligations to a contract research organization
Describing in writing all obligations transferred to a CRO.
312.53: Selecting investigators and monitors
Selecting investigators qualified by training and experience as appropriate experts to investigate the drug.
Selecting a monitor qualified by training and experience to monitor the progress of the investigation.
312.55: Informing investigators
Keeping investigators informed of new observations with respect to adverse effects and safe use.
312.56: Review of ongoing investigations
Monitoring the progress of all clinical investigations being conducted under the IND.
Assuring compliance of all investigators with the signed agreement (Form FDA 1572), the general investigational plan, or the requirements of the IND regulations.
Ending the participation of non-complying investigators, securing unused drug, and notifying the FDA.
Reviewing and evaluating the evidence relating to the safety and effectiveness of the investigational drug. Submitting reports regarding safety to the FDA.
Submitting annual reports to the FDA on the progress of the investigation.
Discontinuing investigations within 5 working days of determining that they present an unreasonable and significant risk to subjects. Notifying investigators, IRB, and FDA of the action.
312.57: Recordkeeping and record retention
Maintaining adequate records showing the receipt, shipment, or other disposition of the investigational drug.
Maintaining complete and accurate records showing financial interests of the investigator as related to the investigation study.
Retaining the records and reports for 2 years after a marketing application is approved for the drug or, if an application is not approved for the drug, until 2 years after the shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
312.58: Inspection of sponsor’s records and reports
Permitting an authorized employee of the FDA to have access to records and reports relating to IND clinical investigations as part of an FDA inspection.
Permitting an authorized employee of the DEA or Department of Justice to have access to records and reports relating to IND clinical investigations involving controlled substances as part of a controlled substance inspection.
312.59: Disposition of unused supply of investigational drug
Assuring the return or alternative disposition of all unused supplies of the investigational drug from investigators.
Maintaining written records of the disposition of the investigational drugs.
312.60: General responsibilities of investigators
Ensuring that an investigation is conducted according to the signed investigator statement, investigational plan, and applicable regulations.
Protecting the rights, safety, and welfare of the subjects.
Controlling the drugs under investigation.
Obtaining the informed consent of each human subject to whom the drug is administered.
312.61: Control of the investigational drug
Administering the drug only to subjects under the personal supervision of the investigator or responsible sub-investigator.
312.62: Investigator recordkeeping and record retention
Maintaining adequate records of the disposition of the drug.
Preparing and maintaining adequate and accurate case histories that record all observations and other pertinent data to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
Retaining records required to be maintained for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated or, if no application is to be filed or if an application is not approved for the drug, until 2 years after the shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
312.64: Investigator reports
Submitting annual reports to FDA on the progress of the clinical investigations.
Reporting any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug.
Providing an adequate report shortly after completion the completion of the study.
Providing sufficient accurate financial information to allow submission of complete and accurate certification or disclosure statements as required. This information shall be promptly updated if relevant changes occur during the course of the study and for 1 year following the completion of the study.
312.66: Assurance of IRB review
Assuring that an IRB will be responsible for the initial and continuing review and approval of the proposed clinical study.
Assuring the prompt reporting to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects and not make any changes in the research with out IRB approval, except where necessary to eliminate hazards to human subjects.
312.68: Inspection of investigator’s records and reports
Permitting properly authorized employees of FDA to have access to, and copy and verify any records or reports made by the investigator.
312.69: Handling of controlled substances
Taking adequate precautions if the investigational drug is a controlled substance.
312.70: Disqualification of a clinical investigator
Accepting written notice from FDA indicating repeated or deliberate failure to comply with the IND requirements or submission of false information.
HMA 26 Dec 2002