CIDSP Practice Test

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CIDSP Practice Test (V1)

Dive into practice questions

Question 1

What is the primary purpose of the Investigator’s Brochure (IB) in a clinical trial?

  1. To provide detailed drug pricing and reimbursement information.
  2. To serve as a legal contract between the sponsor and the investigator.
  3. To compile all nonclinical and clinical data on the investigational product relevant to its study in human subjects.
  4. To outline the patient recruitment strategies for the clinical trial.

Question 2

An investigational drug services pharmacist is reconciling drug accountability records for a Phase 3 study. Which of the following discrepancies requires immediate reporting to the study sponsor and principal investigator?

  1. A one-day delay in recording a returned dose from a patient.
  2. Use of a different brand of saline for reconstitution than originally planned.
  3. A missing vial of the investigational drug that cannot be accounted for.
  4. A patient missing one scheduled dose due to a transportation issue.

Question 3

A refrigerator storing a temperature-sensitive investigational biologic experiences a temperature excursion, rising above the protocol-specified range for four hours overnight. What is the pharmacist’s most critical first step?

  1. Immediately discard all affected vials to prevent patient harm.
  2. Quarantine the affected product and contact the study sponsor for stability data and disposition instructions.
  3. Continue dispensing the drug since the excursion was brief.
  4. Recalibrate the refrigerator and place the drug back into stock.

Question 4

While not directly obtaining informed consent, what is a key role for the investigational drug services pharmacist in the informed consent process?

  1. Signing the informed consent form as a witness for every patient.
  2. Paying the subjects for their participation in the trial.
  3. Ensuring the informed consent form accurately describes the dosing, administration schedule, and potential drug-related risks.
  4. Deciding which patients are eligible to participate in the study.

Answer Key

  • Question 1: C. To compile all nonclinical and clinical data on the investigational product relevant to its study in human subjects. (The IB is the single most comprehensive document summarizing the body of information about an investigational product, crucial for investigators to understand its risks and benefits.)
  • Question 2: C. A missing vial of the investigational drug that cannot be accounted for. (Unaccounted-for investigational product is a major protocol deviation that breaks the chain of custody and could impact study integrity and patient safety, requiring immediate escalation.)
  • Question 3: B. Quarantine the affected product and contact the study sponsor for stability data and disposition instructions. (The sponsor is the only entity with the necessary stability data to determine if the product is still viable. Quarantining the product prevents its use while awaiting this critical determination.)
  • Question 4: C. Ensuring the informed consent form accurately describes the dosing, administration schedule, and potential drug-related risks. (The pharmacist’s expertise is crucial in reviewing the protocol and ICF to ensure the medication-specific details are accurate, clear, and consistent, which is vital for true informed consent.)