|
VIII.1 |
|
Research with investigational or unlicensed test
articles (drugs) |
Objective
Investigators utilizing investigational drugs must conform to FDA regulations covering investigational drugs. The Organization should be able to evaluate whether the FDA regulations regarding investigational articles are applicable.
Policy/Procedure
I. When utilizing investigational drugs, the investigator is responsible for:
A. Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations.
B. Protecting the rights, safety, and welfare of participants under the investigator’s care.
C. The control of drugs under investigation.
II. An investigator shall administer the drug only to participants under the investigator’s personal supervision or under the supervision of a subinvestigator responsible to the investigator.
III. The investigator shall not supply the investigational drug to any person not authorized under this part to receive it.
IV. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by participants.
V. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under Federal regulations.
VI. An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
A. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual’s hospital chart(s), and the nurses’ notes.
B. The case history for each individual shall document that informed consent was obtained prior to participation in the study.
VII. An investigator shall retain records required to be maintained under this part 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 the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.
VIII. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The sponsor is required to submit annual reports to the FDA on the progress of the clinical investigations.
IX. An investigator shall promptly report to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately.
X. An investigator shall provide the sponsor with an adequate report shortly after completion of the investigator’s participation in the investigation.
XI. The clinical investigator shall provide the sponsor with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements as required in the regulations. The clinical investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.
XII. An investigator shall assure that an IRB that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study.
A. The investigator shall also assure that he or she will promptly report to CPHS all changes in the research activity and all unanticipated problems involving risk to human participants or others, and he or she will not make any changes in the research without CPHS approval, except where necessary to eliminate apparent immediate hazards to human participants.
XIII. An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator.
A. The investigator is not required to divulge participant names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.
XIV. If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.
|
Applicable Regulations and Guidelines 21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html
) 21CFR 56( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html
) 38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html
) 45CFR 46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html
) ICH E6 (http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB
) OPRR letter dated May 5,
1995 - Subject: Exempt Research and
Research That May Undergo Expedited Review (http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc95-02.htm
) OHRP
Guidance on the Involvement of Prisoners in Research dated May 23, 2003 (http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.pdf |
|
Return to Policies and Procedures Home
Page |
|
Updated 5/2007, Report
broken links |