CIDSP Certification Review

CIDSP Certification Review

A Review Guide for the Certified Investigational Drug Services Pharmacist (CIDSP) Exam

AE: Adverse Event

ALCOA-C: Attributable, Legible, Contemporaneous, Original, Accurate, Complete

CFR: Code of Federal Regulations

CRA: Clinical Research Associate

CRF: Case Report Form

CRO: Contract Research Organization

CSP: Compounded Sterile Preparation

CTA: Clinical Trial Agreement

DAF: Drug Accountability Form

DSMB: Data and Safety Monitoring Board

EAP: Expanded Access Program

EDC: Electronic Data Capture

FDA: Food and Drug Administration

GCP: Good Clinical Practice

IB: Investigator's Brochure

ICF: Informed Consent Form

ICH: International Council for Harmonisation

IDS: Investigational Drug Service

IND: Investigational New Drug

IP: Investigational Product

IRB: Institutional Review Board

IVRS/IWRS: Interactive Voice/Web Response System

LOA: Letter of Authorization

MOP: Manual of Operations

NCI: National Cancer Institute

OHRP: Office for Human Research Protections

PI: Principal Investigator

SAE: Serious Adverse Event

SIV: Site Initiation Visit

SOP: Standard Operating Procedure

  • Phases of Clinical Trials: Understanding the purpose of each phase: Phase 1 (safety, dosage), Phase 2 (efficacy, side effects), Phase 3 (large-scale efficacy, comparison to standard), and Phase 4 (post-marketing surveillance).
  • The Role of the IDS: The IDS pharmacy is responsible for the storage, handling, preparation, dispensing, and accountability of all investigational products (IPs) used in clinical trials at an institution.
  • Key Study Personnel: Differentiating the roles of the Sponsor (initiates and funds the trial), Principal Investigator (PI) (responsible for conducting the trial at a site), Clinical Research Coordinator (CRC) (manages daily study activities), and Clinical Research Associate (CRA) (monitors the trial on behalf of the sponsor).
  • The Study Protocol: The single most important document for a clinical trial. It is a detailed written plan that describes the objectives, design, methodology, statistical considerations, and organization of a trial. The IDS pharmacist must adhere to it strictly.
  • Investigator's Brochure (IB): A compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.
  • Good Clinical Practice (GCP): An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. The ICH E6 guideline is the key GCP document.
  • Institutional Review Board (IRB): An independent committee responsible for reviewing and approving all research involving human subjects to ensure the protection of their rights, safety, and welfare.
  • Informed Consent: The process by which a subject voluntarily confirms their willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to their decision. It is a process, not just a form.
  • Code of Federal Regulations (CFR): Understanding key FDA regulations governing clinical trials, including 21 CFR Part 50 (Protection of Human Subjects), 21 CFR Part 56 (IRBs), and 21 CFR Part 312 (Investigational New Drug Application).
  • The Belmont Report: The foundational document for the ethics of human subjects research in the U.S., outlining three core principles: Respect for Persons, Beneficence, and Justice.
  • HIPAA in Research: Understanding how the Health Insurance Portability and Accountability Act applies to research, including the use of authorizations to access Protected Health Information (PHI).
  • Procurement & Receipt: The process of ordering and receiving IP from the sponsor or CRO, including temperature monitoring during shipment and quarantine until release.
  • Storage & Security: Storing IP according to the protocol-specified conditions (e.g., temperature, light protection) in a secure, limited-access area separate from commercial drug stock.
  • Temperature Monitoring: The critical requirement for continuous temperature monitoring of refrigerators, freezers, and ambient storage areas, with documented excursion management.
  • Drug Accountability: Meticulously documenting the receipt, dispensing, and return/destruction of every single dosage unit of the IP on Drug Accountability Forms (DAFs). This is a primary focus of monitor visits and audits.
  • Inventory Management: Managing inventory to ensure an adequate supply for active subjects while preventing expiration and minimizing waste.
  • Returns & Destruction: Following the sponsor's specific procedures for returning unused IP or destroying it on-site, with complete documentation.
  • Site Initiation Visit (SIV): The formal visit where the sponsor's team trains the site staff on the protocol and procedures before the first subject is enrolled. The IDS pharmacist is a key participant.
  • Order Review & Verification: Reviewing IP orders against the study protocol to ensure the subject is eligible, the dose is correct for the specified treatment arm and cycle, and all required labs are within range.
  • Dispensing & Labeling: Dispensing IP with specific, protocol-required labeling that clearly identifies it as an investigational product.
  • Blinding & Randomization: Maintaining the blind is critical for study integrity. This involves managing randomization schemes (often via an IVRS/IWRS) and preparing active and placebo products that are indistinguishable.
  • Patient Counseling: Educating study subjects on the proper use, storage, and handling of their IP, as well as procedures for returning unused medication.
  • Adverse Event (AE) Reporting: The pharmacist's role in identifying and reporting potential AEs to the PI and study team. Understanding the definition of a Serious Adverse Event (SAE) is crucial.
  • Adherence to USP Standards: All compounding for clinical trials must adhere to USP <795> (non-sterile), <797> (sterile), and <800> (hazardous drugs) as the minimum standard of practice.
  • Protocol-Specific Instructions: The study protocol and pharmacy manual will often contain very specific, detailed instructions for compounding that must be followed exactly.
  • Blinded Preparations: The complex process of preparing active and placebo CSPs that are identical in appearance (color, volume, turbidity) to maintain the study blind. This may involve using special filters or over-wrapping.
  • Stability & Beyond-Use Dating (BUD): The BUD for a compounded IP is determined by the stability data provided by the sponsor in the pharmacy manual, which may be longer or shorter than the default USP BUDs.
  • Documentation: Meticulous documentation of the compounding process on specific compounding records, including lot numbers of all components used.
  • Sponsor Monitoring Visits: Routine visits by the CRA to review study conduct, including a thorough review of all IDS records. Drug accountability is a primary focus.
  • Audits vs. Inspections: Differentiating between Audits (conducted by the sponsor or CRO to ensure compliance) and Inspections (conducted by a regulatory agency like the FDA).
  • Preparing for an Audit/Inspection: Ensuring all documentation is organized, complete, and readily available. The goal is to be "audit-ready" at all times.
  • ALCOA-C Principles: The standard for good documentation practice. All records must be Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.
  • Standard Operating Procedures (SOPs): The importance of having detailed, written SOPs for all IDS functions, from receipt of IP to staff training.

Dose Verification Calculations

The ability to independently calculate and verify a subject's dose based on the protocol, using metrics like Body Surface Area (BSA), weight (kg), or AUC. This is a critical safety check.

Drug Accountability Reconciliation

(Starting Inventory) + (Received) - (Dispensed) - (Returned/Destroyed) = Expected On-Hand Inventory

This calculation must balance to zero. Any discrepancy must be investigated and documented immediately.

ALCOA-C Documentation Principles

Attributable: Who performed an action and when.
Legible: Can be read and understood.
Contemporaneous: Recorded at the time the action was performed.
Original: The first record or a certified copy.
Accurate: Correct and truthful.
Complete: All necessary information is present.

  • The Protocol is King: The absolute, non-negotiable principle that the study protocol must be followed exactly. There is no room for professional judgment that deviates from the protocol.
  • If it Wasn't Documented, it Didn't Happen: The foundational concept of clinical research. Meticulous, contemporaneous documentation is essential to ensure data integrity and regulatory compliance.
  • Guardian of the Blind and the Supply: The IDS pharmacist has the dual, critical responsibilities of maintaining the study blind and ensuring 100% accountability for every dosage unit of the investigational product.
  • Patient Safety is the Highest Priority: While the goal of research is to answer a scientific question, the safety and welfare of the human subjects participating in the trial always takes precedence.
  • A Bridge Between Research and Pharmacy Operations: The IDS pharmacist must be an expert in both the highly regulated world of clinical research and the operational complexities of pharmacy practice.
  • Details Matter Immensely: In the world of investigational drugs, small details (e.g., a temperature excursion, a documentation error) can have major consequences for patient safety and study integrity.
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