No products in the cart.
CIDSP Interactive Case Studies
Certified Investigational Drug Services Pharmacist (CIDSP)
The Scenario: Managing a Double-Blind Clinical Trial
You are the lead CIDSP at an academic medical center selected to participate in a Phase III, randomized, double-blind, placebo-controlled trial for a new oral medication, "Cardia-Protect." Your role is to set up the pharmacy services for the trial, ensuring proper handling, blinding, dispensing, and accountability of the investigational product (IP).
Study Protocol & Drug Information
Study Drug Information
- Investigational Product (IP): Cardia-Protect 10mg tablets
- Placebo: Matching tablets (identical in appearance)
- Packaging: Both IP and placebo are supplied in identical bottles with unique kit numbers.
- Randomization: 1:1 via an Interactive Web Response System (IWRS).
Protocol Excerpt
- The Investigational Drug Services (IDS) pharmacy is the only unblinded department.
- The IDS pharmacy is responsible for maintaining the study blind for all other site personnel and patients.
- Accurate drug accountability logs must be maintained for every dose dispensed and returned.
- A procedure for emergency unblinding must be in place for medical emergencies.
Your Task
1. What is the primary purpose of a "double-blind" study design, and what is the IDS pharmacy's key role in maintaining it?
Answer:
The purpose is to **prevent bias**. Neither the participants nor the study staff know who is receiving the IP versus the placebo, which prevents expectations from influencing outcomes. The IDS pharmacy's role is to act as the **"firewall"**; the unblinded IDS pharmacist accesses the randomization system, prepares the assigned treatment, and dispenses it in a way that does not reveal its identity, thereby protecting the study's scientific integrity.
2. A trial patient is admitted with a life-threatening emergency. The medical team needs to know the patient's treatment assignment. What is this process called, and who is authorized to perform it?
Answer:
This is called **emergency unblinding**. Per the protocol, this action is restricted to authorized, unblinded personnel to be performed only in a true medical emergency where knowledge of the treatment is essential for patient care. This is typically the on-call **IDS pharmacist** or the study's Principal Investigator (PI). The process must be clearly documented, including the reason for unblinding and who was notified.
The Scenario: Reconciling an Accountability Discrepancy
You are conducting the monthly physical inventory for the "NEPHRO-STAT" trial. After counting the physical stock of the investigational capsules, you discover that the count does not match the expected inventory on your Drug Accountability Record (DAR). As the CIDSP, you must immediately investigate the source of the discrepancy, resolve it, and create proper documentation that would satisfy an auditor.
Inventory & Accountability Records
Drug Accountability Record (DAR) for NEPHRO-STAT 10mg Capsules
| Date | Action | Patient ID | Qty In | Qty Out | Balance | Initials |
|---|---|---|---|---|---|---|
| 07/01 | Beginning Inv. | - | - | - | 120 | - |
| 07/05 | Dispense | 001-001 | - | 30 | 90 | JS |
| 07/12 | Dispense | 001-002 | - | 30 | 60 | RS |
| 07/15 | Return | 001-001 | 5 | - | 65 | RS |
| 07/20 | Dispense | 001-003 | - | 30 | 35 | JS |
Inventory Findings
- Expected Inventory from DAR: 35 capsules.
- Your Physical Inventory Count: 34 capsules.
- Note found with DAR: A sticky note says: "07/20 - Pt 001-003, dropped 1 cap on floor, threw in trash."
Your Task
1. What is the most likely cause of the one-capsule discrepancy?
Answer:
The most likely cause is the undocumented destruction of one capsule that was dropped during the dispensing process for patient 001-003 on 07/20. The dispensing staff failed to properly record this event on the official DAR, leading to a mismatch between the paper record and the physical stock.
2. How must you properly document this event on the DAR to resolve the discrepancy for an audit?
Answer:
You must make a new, contemporaneous entry on the next available line of the DAR. The entry must be clear and attributable:
- Date: The current date (the date of the discovery).
- Action/Explanation: Write a clear explanation, such as "Reconciliation: 1 capsule dropped on 07/20 during dispense to pt 001-003 and destroyed. See Deviation Note."
- Qty Out: Enter "1" in the quantity out column.
- Balance: Calculate the new, correct balance (35 - 1 = 34).
- Initials: Sign/initial and date the new entry.
3. A sticky note is not proper documentation. What formal document must you create to support the DAR entry and satisfy a sponsor auditor?
Answer:
You must complete a formal Protocol Deviation Report or a Memo to File. This document is a key part of the study record and provides a detailed narrative of events that do not follow the protocol or standard procedures. It should include the date of the event, date of discovery, a full description of what happened (the dropped capsule), the root cause (human error), and the corrective action taken (the reconciliation on the DAR and this memo). This creates a transparent and complete record for any future audits.
The Scenario: Preparing for a Sponsor Audit
The sponsor for the "ONCO-TRIAL" has notified you that a routine monitoring visit (audit) is scheduled in two weeks. As the lead CIDSP, you are conducting a self-audit of all study-related documentation to identify and correct any potential findings before the monitor arrives. You must review your records with the critical eye of an auditor.
Self-Audit Findings
Temperature Log Excerpt (Refrigerator #1)
| Date | Temp (°C) | Notes |
|---|---|---|
| 07/14 | 4.5 | - |
| 07/15 | 5.0 | - |
| 07/16 | -- | No entry |
| 07/17 | 9.5 | "Temp high, moved IP, called maint." |
Protocol requires storage between 2-8°C.
Other Potential Issues
- Training Log: A new pharmacist dispensed an IP dose last week, but the Principal Investigator has not yet signed her name on the official Delegation of Authority Log.
- Accountability Record: A correction to a calculation error was made using white-out.
- Prescription: One prescription for the IP was written on a standard hospital prescription blank, not the sponsor-provided study-specific prescription form.
Your Task
1. You have found a temperature excursion on 07/17. What three essential actions must you take and document regarding this excursion?
Answer:
- Quarantine the Product: All IP that was in the refrigerator during the excursion must be immediately quarantined and labeled "DO NOT USE - PENDING SPONSOR DISPOSITION."
- Notify the Sponsor/Monitor: You must immediately report the temperature excursion to the study sponsor, providing the temperature logs and a list of all affected IP.
- Await Disposition: The sponsor is the only entity that can determine if the drug is still usable, often by consulting stability data. You must wait for their official written disposition (e.g., "OK to use" or "Destroy") before taking any further action with the product.
2. An auditor will cite the use of white-out on the accountability record as a deficiency. What is the principle of Good Documentation Practice (GDP) that this violates?
Answer:
This violates the principle that all data must be Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA). Using white-out obscures the original entry, making the record no longer "original" or transparent. The proper way to correct an error is to draw a single line through it, write the correct information, and then initial and date the change, so the original data is still legible and an audit trail exists.
3. For each of the three "Other Potential Issues" (Training Log, White-Out, Prescription Form), what is the corrective action you must take before the audit?
Answer:
- Training Log: Immediately have the Principal Investigator sign and date the Delegation of Authority Log to officially delegate dispensing duties to the new pharmacist. File a deviation note explaining the single dose was dispensed prior to the formal signature date.
- White-Out on DAR: This cannot be undone, but you can mitigate it. Create a Memo to File that clearly states a correction was made improperly with white-out on a specific date, explains what the original error was, what the correction should have been, and states that staff have been re-educated on proper GDP for corrections.
- Wrong Prescription Form: File a deviation note explaining that the order was received on a non-study form. The note should confirm that the pharmacist verified all elements of the order (drug, dose, route, patient) against the protocol before dispensing to ensure patient safety was not compromised.
