Pharmacists Responsibilities in Clinical Studies

Mike R Sather, PhD

Crystal L Harris, PharmDFebruary 26, 2004

Today’s Presentation

Rules & Regulations Investigator’s Commitments Pharmacy Essential Documents Audits/Inspections Future of Research Pharmacist

Rules & RegulationsGoverning VA Research

FDA GCP Regulations 21 CFR 54 – Financial Disclosure 21 CFR 56 – IRB 21 CFR 312 – IND 21 CFR 314 – NDA 21 CFR 812 – IDE 21 CFR 814 – PMA (premarket approval application - devices)

Rules & RegulationsGoverning VA Research

ICH GCP Guidelines 45 CFR 46 (Common Rule) – Protection of

Human Subjects in federally funded research 38 CFR 17 & 18 (VA Research) VHA Handbook 1200.5 M-2, Part VII, Chapter 6

M-2, Part VII -Basic Policy

Pharmacy is charged with: Protecting the patient, staff, facility, and

quality of the study. Assuring the PI is qualified Assuring R&D/IRB approval Assuring informed consent obtained

Roles and Responsibilities in Clinical Trials - Research Team

IRB Sponsor

Subject

Pharmacy Investigator

RolesandResponsibilities inClinical Trials Clinical Trials --Research Team

The reputation of clinical research depends on all of us.

Investigator’s Commitment

Drugs - Form 1572 Devices – Investigator’s Signed Agreement

Form 1572 – The CommitmentInvestigator agrees to:• Conduct the study in accordance with the

relevant, current, protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.

• Personally conduct or supervise the described investigations(s).

Form 1572 – The CommitmentInvestigator agrees to:

• Inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 21CFR Part 50 and Institutional Review Board (IRB) review and approval in 21CFR Part 56 are met.

• Signed copy before filling initial Rx

Form 1572 – The CommitmentInvestigator agrees to:

• Report adverse experiences that occur in the course of the investigation(s) in accordance with CFR 21 312.64.

• Read and understand the information in the investigator’s brochure, including the potential risks and side effects of the drug.

• Ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations in meeting the above commitments.

Form 1572 – The CommitmentInvestigator agrees to:

• Maintain adequate and accurate records in accordance with 21 CFR 312.62 and make those records available for inspection in accordance with 21 CFR 312.68.

• Drug accountability records

• Protect Patient and Public Safety

• Protect Data Integrity

Form 1572 – The CommitmentInvestigator agrees to:• Ensure that an IRB that complies with the requirements of 21

CFR Part 56 will be responsible for the initial and continuing review and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects and others. Additionally, I will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.

• Comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR Part 312.

“NON – NEGOTIABLE NINE”

Essential Documents – Pharmacy

FDA regulations M2 Part VII Pharmacy Policies and Procedures

Essential Documents – Pharmacy

Copy of complete protocol as approved by IRB.

Investigational Drug Information Record (10-9012)

Documentation on appropriate form of IRB approval

Complete summary of dispensing & record keeping procedures & responsibilities.

Essential Documents – Pharmacy

Name of principal investigator & authorized prescribers of investigational drug

Copy of each patient’s informed consent

ESSENTIAL

DOCUMENTS

Inspections, Audits, Reviews….

“The meeting of this watchdog agency will come to order . . .”

GROUPS THAT PROMOTE QUALITY IN RESEARCHFDA* - Inspects IRBs & InvestigatorsOHRP (HHS) - Inspects Research Protection

Programs

ORO (VA) - Inspect VA Research ProgramsNCQA - Accredits Research Programs AAHRPP - Accredits Research ProgramsSponsor - Inspects its investigators IRB - May review Investigator records

*If sponsor plans data submission to FDA

Recent FDA Findings

Protocol Non-adherence 27%Patient Records Inadequate / Inaccurate 20% Consent Form Missing Required Elements 15% Inadequate AE reporting to sponsor 15% Poor Drug Accountability 9%Consent Obtained & Documented Improper 8% Failure to Inform IRB (AEs, Progress, etc) 7% Failure to Obtain Consent Before Procedures 2% Failure to Obtain Required IRB Approvals 2%

RESULTS PUBLISHED ANNUALLY

Disaster Preparedness

Emergency Code Envelopes Unblinding of patients

Future of Research Pharmacist

Research Pharmacist……

You are a member of one of the largest and most productive research program in the world……VA Research & Development

VA Research Pharmacist Meeting

First time gathering Continue to network with each other Organize annual meeting? Training and education

Issues… M2 Part VII Chapter 6

Pharmacist on R& D Committee Pharmacy Service oversight?

ADR reporting Agent for Investigation Drug Unblinding Co-Pays for Investigational vs. Marketed Study Drugs Managing study patient drop-ins VAF 10-9012 use for marketed study drugs

Electronic versus paper documentation Investigational Devices

Discussion

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