Clinical Research with Drugs/Biologics and Devices & Good Clinical Practices

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1 Clinical Research with Drugs/Biologics and Devices & Good Clinical Practices Jason Jobson, BLS, CCRP Research Compliance Officer Oklahoma City VA Medical Center October 2017 Goals Investigational New Drug (IND) and Investigational Device Exemption (IDE) Applications What are they and why are they needed Who applies for them What does it mean when you are assigned an IND/IDE number Good Clinical Practices What are they How they apply to your research INVESTIGATIONAL NEW DRUG (IND) APPLICATION Is a request for authorization from the FDA to utilize a drug or biological product in humans for the purposes of research. 1

2 Documentation of a Valid IND Number IRB Policy 502A (Drugs) & 502B (Biologics) Section The IRB requires investigators to provide the IND number when submitting new protocols for industry-sponsored or investigator-initiated research. IND Exemption Criteria [21CFR312(b)] No new indication or other significant labeling change Lawfully marketed; not in support of a significant change in advertised claims No change in administration route/dose or use in patient population that changes risk/benefit Must have IRB approval and obtain informed consent from study participants Must be in compliance with promoting/ charging (21CFR312.7) IND Application Process Forms 1571, 1572 and 3674 Protocol Informed Consent document CV of PI and sub-i (s) Additional Information andapproved/approvalapplications/investigatalnewdrugindapplication/ucm htm 2

3 FDA Outcomes FDA determines Exempt from IND Submit correspondence to the IRB Study proceeds FDA issues an IND PI becomes Sponsor-Investigator Personally accountable for 21CFR312 Annual reporting requirements Adverse event reporting Notification to FDA for changes to protocol Device Classes Regulated based on the degree of control necessary to assure that the device is safe and effective. Class I: Must meet general controls Class II: Must meet performance standards Class III: Supports or sustains human life, or Is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury Devices, IDE and Risks Significant Risk (SR): Intended as an implant; or, Supports or sustains human life; or, Has a substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; or, Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. Non-Significant Risk (NSR): Doesn t meet SR criteria 3

4 INVESTIGATIONAL DEVICE EXEMPTION (IDE) An investigational device exemption (IDE) allows the device being researched to be used in a clinical study in order to collect safety and effectiveness data without going through the Premarket Approval Application (PMA) process. Documentation of a Valid IDE Number IRB Policy 502C Section The IRB requires investigators to provide the IDE number when they submit new protocols for industry-sponsored or investigator-initiated research. IDE Exemptions Five Main Categories 510(K) device used according to approved labeling Diagnostic device Device undergoing consumer preference testing Device solely for veterinary or research animal use Custom device [21CFR812.3] 4

5 IDE Submission There are no standard forms Provide letter Attach support documents Refer to 21CFR rketyourdevice/investigationaldeviceexemptionide/ucm htm FDA Outcomes FDA determines Exempt from IDE Submit correspondence to the IRB Study proceeds FDA issues an Approval with Condition(s) Can begin enrollment after you receive IRB approval Must address issues identified within 45 days from the date of the FDAs decision letter FDA Outcomes (cont d.) FDA issues an Approval PI becomes Sponsor-Investigator May begin study Personally accountable for 21CFR812 Annual reporting requirements Adverse event reporting Notification to FDA for changes to protocol, investigators 5

6 FDA Outcomes (cont d.) FDA issues a Staged Approval PI becomes Sponsor-Investigator May begin study Personally accountable for 21CFR812 Annual reporting requirements Adverse event reporting Notification to FDA for changes to protocol, investigators FDA Outcomes FDA Denies the IDE You may not begin study until all issues identified by the FDA have been satisfactorily resolved. Good Clinical Practices (GCP) 6

7 GCP as defined by FDA There are 12 potential Federal Regulations that must be followed with regard to conducting research with drugs, biologics, and devices. The most common regulations applicable to an investigator-initiated study are: 21 CFR 50 - Human Subject Protection 21 CFR 54 - Financial Disclosures 21 CFR Current Good Manufacturing Practice In Manufacturing, Processing, Packaging, Or Holding Of Drugs 21 CFR Investigational New Drug Application 21 CFR 812 Investigational Device Exemption International Conference on Harmonization The International Conference on Harmonization (ICH) Good Clinical Practice is a standard that the European Union, Japan, and the United States follow in order to facilitate acceptance of clinical data by the regulatory authorities in those jurisdictions and to contribute to the protection of public health from an international perspective. International Conference on Harmonization ICH Good Clinical Practice is based on guidelines Institutional Review Boards Sponsors Investigators 7

8 What is an ICH guideline? A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. FDA GCP Guidance: egulatoryinformation/guidances/ucm pdf What are Essential Documents? Those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. Essential Documents Investigator Brochure / Package Insert Protocol Modifications / Notifications All IRB approved Consent versions (stamped) Financial Disclosures Delegation of Authority Log Written Materials to be Distributed 8

9 Essential Documents cont d IRB Rosters IRB Approval Letters Regulatory Agency Authorization/Approval Investigator CVs (PI and sub-is) Copies of Annual / Interim Reports (IRB & FDA) Essential Documents cont d Participant Screening & Enrollment Log Participant Identification List Participant Source Documents Original, signed and dated Consent and HIPAA documents Study test article Dispensation Log Common QI Findings Not following the approved protocol Deviations and Unanticipated Problems Missing original, signed HIPAA and Consent documents Using outdated HIPAA and Consent Documents Failure to follow inclusion/exclusion criteria Home made case report forms lack specificity 9

10 A Well-Run Research Office Compliance with: Federal Regulations and ICH Guidelines IRB processes Membership to Professional Organizations: SoCRA ( ACRP ( Well-trained staff: Attention to detail, thoroughness, pride in work Sufficient office policies/procedures Open lines of Communication with each other as well as with the IRB Thank You Any Questions or Discussion? IRB: Jason s office: