fda history

8/8/2019 FDA History

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FDA Guid e lin es to co nd uct c lin ical tri al sy 21 CFR part 11- Electronic submission and Electronic

signaturey

21 CFR part 50- Protection of human subjectsy 21 CFR part 54- Financial Disclosure by Clinical

Investigatorsy 21 CFR part 56- Institutional Review Boardy 21 CFR part 312- Investigational new drug

applicationy 21 CFR part 314- Application for FDA Approval to

Market a New Drug9/13/2010 13


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21CFR p

art

11

y Part 11 covers: All aspects of electronic records, includingsignatures; integrity and authenticity; record creation; audit

trails and archivingy Part 11 requires: Electronic records that are "created, modified,

maintained, archived, retrieved, or transmitted, must be protected by procedures and controls to "ensure theauthenticity, integrity and the confidentiality of electronic

records, and to ensure that the signer cannot readily refuse thedocument as not genuine."y Part 11 goals : To ensure electronic records and signatures

are at least as authentic and traceable as those on paper.


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21 CFR pa rt 50: Hum an SubjectProtectio n

y subpart A - General Provisionsy subpart B - Informed Consent of Human Subjectsy subpart C - (Reserved)y subpart D - Additional Safeguards for Children in

Clinical Investigations


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21 CFR part 54: FinancialDisclosure by clinical investigators

y FDA requires financial disclosure from Principal Investigators, Sub-investigators and their spouses and dependent children, if applicable.

y If you are listed on the 1572, you will be asked to complete afinancial disclosure form at the beginning of the trial (and update theinformation as relevant, including one year following studycompletion).

54.1 - Purpose.54.2 - Definitions.54.3 - Scope.54.4 - Certification and disclosure requirements.54.5 - Agency evaluation of financial interests.54.6 - Record keeping and record retention.


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Investig

ator/Site Respo

nsibi

lities

FORM FDA 1572:y Conduct the study in accordance with the protocol. Notify

sponsor otherwisey

Personally conduct or supervise the study.y Explain the study and possible risks and benefits to subjectsand obtain written informed consents prior to subjects

participation in the study.y Inform All staff participating in the conduct of the study of

their responsibilities.y Read and understand ALL relevant study information1. the protocol2. the investigators brochure,3. the package inserts

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In vestig a tor/Site Respo n sibi litiesFORM FDA 1572 Contdy Promptly report adverse events to the sponsor and the

IRB.y Maintain adequate and accurate records and make those

available for inspectiony Ensure that an IRB complies with the requirements

including initial and continuing review and approvaly

Report all changes in research and all unanticipated problems involving risks to the IRB.y Will not implement changes in research without IRB

approval, except where necessary to eliminate harm tosubjects.

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21 CFR Pa rt 56: In stitutio nal Review Bo a rd s

y Subpart A - General Provisionsy

Subpart B - Organization and Personnely Subpart C - IRB Functions and Operationsy Subpart D - Records and Reportsy Subpart E - Administrative Actions for Noncompliance

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21C

FR 312: Investigational new drug application

y Subpart A - General Provisionsy Subpart B - Investigations New Drug Application (IND)y Subpart C - Administrative Actionsy Subpart D - Responsibilities of Sponsors and Investigatorsy Subpart E - Drugs Intended to Treat Life Threatening and

Severely Debilitating Illnessesy

Subpart F - Miscellaneousy Subpart G - Drugs for Investigational Use in Laboratory Research Animals or in vitro Tests

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21 CFR pa rt 3 14 : App lica tio n s For FDAApprov al To Ma rket A New Drug

y Subpart A - General Provisionsy Subpart B - Applicationsy Subpart C - Abbreviated Applicationsy Subpart D - FDA Action on Applications and

Abbreviated Applicationsy Subpart E - Hearing Procedures for New Drugsy Subpart F - [Reserved]y Subpart G - Miscellaneous Provisionsy Subpart H - Accelerated Approval of New Drugs

for Serious or Life-Threatening Illnesses9/13/2010 21

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