CASP Module 21, Section 2: Investigational Drug Services & IND Compliance
MODULE 21: THE PHARMACIST’S ROLE IN RESEARCH & DRUG DEVELOPMENT

Section 21.2: Investigational Drug Services & IND Compliance

A deep dive into the specialized operations for handling investigational drugs, including storage, dispensing, accountability logs, blinding protocols, and adherence to Investigational New Drug (IND) regulations.

SECTION 21.2

The Pharmacy as a Regulated Fortress

Building the operational and regulatory framework for handling investigational products.

21.2.1 The “Why”: From Patient Safety to Data Integrity

As a practicing specialty pharmacist, your entire professional life is built on a foundation of patient safety. You are the final checkpoint ensuring the right patient gets the right drug at the right dose. When you step into the world of Investigational Drug Services (IDS), this core responsibility remains, but a second, equally important mandate is added: data integrity.

An Investigational New Drug (IND) is not a therapy; it is a scientific question. Every tablet dispensed, every vial stored, and every temperature recorded is not just a clinical action—it is a data point. If that data is flawed, the entire multi-billion dollar, multi-year experiment can be invalidated. An uncalibrated thermometer, a miscounted return, or a missing signature on a log can literally be the difference between a drug’s approval and its rejection.

This is why an IDS pharmacy cannot be just a locked cabinet in the corner of your main pharmacy. It must be a purpose-built, highly-regulated, and obsessively-documented “fortress.” It is a pharmacy that operates under a different set of laws, a different philosophy, and a much, much higher burden of proof. Your existing skills in precision, documentation, and process adherence are the perfect foundation. This section will build the fortress walls around that foundation, giving you a masterclass in the specific regulations and operations that define an IDS pharmacist.

Pharmacist Analogy: The Bank Vault Manager

Think of your standard specialty pharmacy practice as a high-end commercial bank. You have high-value products (specialty drugs), robust security, and complex procedures for handling transactions (dispensing). You are audited by the Board of Pharmacy (the bank examiners) to ensure you are protecting your customers and their assets. This is a high-trust, high-skill environment.

An Investigational Drug Service (IDS) pharmacy, by contrast, is the Federal Reserve Gold Vault.

  • The “Asset” is Different: The gold (the investigational drug) is not just valuable; it’s irreplaceable and untraceable to the naked eye (like a blinded kit). Its value is in its scientific potential, and it’s on loan from the government (the FDA/Sponsor via the IND).
  • Access is Different: At a bank, many tellers have access. At the vault, only a tiny handful of named, background-checked, and specially-trained individuals (those on the “Delegation of Authority Log”) can even enter the room.
  • The “Transaction” is Different: You don’t just “dispense” a drug. You log a chain of custody. Every single unit (tablet, vial) that enters the vault is tracked on a meticulous, un-editable ledger (the “Drug Accountability Log”).
  • The Audit is Different: A bank examiner checks your processes. A vault auditor (the FDA) shows up and says, “The records show you received 10,000 gold bars. I am going to physically count all 10,000, and your logs must account for every single one. If your log says a bar was moved at 3:15 PM, I will check the security footage and access logs to prove it.”

Your job as an IDS pharmacist is to be that vault manager. The product is secondary to the process, the documentation, and the absolute, verifiable audit trail. This is the mindset of 21 CFR and Good Clinical Practice.

21.2.2 The Regulatory Cornerstone: 21 CFR 312 and the IND

To operate the “vault,” you must understand the laws that govern it. Your entire practice within IDS is dictated by the FDA, specifically the Code of Federal Regulations (CFR), Title 21, Part 312: Investigational New Drug Application (IND). This is the law. While you are also governed by your state’s Board of Pharmacy for your license, 21 CFR 312 is the “protocol” for the entire study.

An IND application is the legal document a sponsor (pharma company) files with the FDA to get permission to give an unapproved drug to humans. Once the FDA approves the IND, the “study may proceed,” and every person who touches that drug—from the sponsor to the Principal Investigator (PI) to you, the pharmacist—is now legally bound by the rules of that IND.

As a pharmacist, you are almost always a designee of the Principal Investigator (PI). The PI is the one person legally responsible for the entire trial at your site. They cannot manage the drug, so they delegate this task to you. This is not a casual hand-off; it is a formal, legal delegation of duty.

The “Contract”: The Delegation of Authority (DOA) Log

This is the single most important document defining your role. The Delegation of Authority (DOA) Log (or “Site Signature Log”) is a master list of every person at the trial site and the *specific tasks* the PI has delegated to them.

If your name is not on this log, you cannot legally touch an investigational drug. Period.

Example: Delegation of Authority (DOA) Log – Pharmacy Section
Name Role Task 1: Receive IP Task 2: Dispense IP Task 3: Maintain D-Logs Task 4: Counsel Patient Start Date End Date PI Signature & Date
Jane Smith, RPh IDS Pharmacist Lead 2024-01-15 [PI Signature] 1/15/24
Paul Jones, RPh IDS Staff Pharmacist 2024-02-01 [PI Signature] 2/01/24
Alan Tse, CPhT IDS Technician 2024-02-15 [PI Signature] 2/15/24

Notice the granularity. In this example, Paul Jones can dispense the drug but is not delegated to counsel the patient. Alan Tse, the technician, is only allowed to receive and unpack shipments. If an auditor sees Alan’s initials on a dispensing log, it is a major regulatory violation. Your pharmacy’s internal SOPs (Standard Operating Procedures) must reflect and enforce what is on this log.

The Law You Must Know: 21 CFR 312, Subpart D

Subpart D outlines the “Responsibilities of Sponsors and Investigators.” Your entire workflow is built to ensure the PI is compliant with these rules. The two most important are:

  • 21 CFR 312.60 (Investigator Responsibilities): The PI must “ensure… that the investigational drug is administered only to subjects under the investigator’s personal supervision or under the supervision of a sub-investigator responsible to the investigator.” Your delegation makes you that sub-investigator for pharmacy.
  • 21 CFR 312.62 (Investigator Recordkeeping): This is the big one. The PI must maintain “adequate and accurate case histories” and, most importantly, “records of the disposition of the drug.” This includes:
    • (a) Records of disposition: “An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.”
    • (b) Case histories: “An investigator is required to prepare and maintain adequate and accurate case histories…[including] records of exposure to the drug.”

The Drug Accountability Log (D-Log) is your direct answer to the legal mandate of 21 CFR 312.62(a). It is not a “best practice” or a “good idea”; it is the physical manifestation of your compliance with federal law.

GCP vs. 21 CFR: What’s the Difference?

You will hear “GCP-compliant” and “21 CFR-compliant” used constantly. Here’s the simple translation:

  • 21 CFR 312: This is The Law in the United States. It’s what the FDA can use to shut you down, invalidate your data, or even (in extreme cases) bring criminal charges. It is binding.
  • ICH E6 (GCP): This is the International Standard (International Council for Harmonisation, E6: Good Clinical Practice). This is a set of ethical and quality guidelines for all global trials. While not *technically* law in the US, the FDA has adopted GCP principles, and 21 CFR is largely harmonized with it.

The Takeaway: You live by 21 CFR. You operate by GCP. All your staff must be trained on GCP principles, which are the “how-to” guide for being compliant with the law.

21.2.3 Masterclass: Storage, Environment, and 21 CFR Part 11

This is the physical “fortress” of your IDS. If the D-Log is the legal record, the storage system is the physical security that guarantees the product’s integrity. Failure here means you are dispensing an adulterated product, which endangers the patient and destroys the data.

The Three Pillars of Investigational Product Storage
1. Segregation & Security

This is the #1 rule. Investigational Products (IPs) can NEVER be co-mingled with commercial stock. Not even for 5 minutes.

  • Dedicated Space: A separate, locked room or a clearly demarcated, physically separate area within the pharmacy.
  • Dedicated Equipment: Dedicated, labeled shelves. Dedicated, labeled refrigerators and freezers.
  • Access Control: Access must be strictly limited to personnel listed on the Delegation of Authority (DOA) log. This is often enforced by a keycard or a physical key log.

2. Environmental Control

The product must be stored at the exact temperature specified in the protocol.

  • Ambient (CRT): Controlled Room Temperature (typically 20°C to 25°C, with excursions allowed from 15°C to 30°C per USP <659>).
  • Refrigerated: 2°C to 8°C.
  • Frozen: -15°C to -25°C.
  • Ultra-Low: -70°C to -90°C (for biologics, vaccines, mRNA).

3. Continuous Monitoring

This is the most critical and highest-tech component. You cannot use a min/max thermometer from your retail pharmacy.

  • Calibrated Probes: Must use a calibrated, NIST-traceable digital data logger (DDL).
  • 24/7/365 Alarming: The system must be able to send an alert (email, text, auto-call) to an on-call pharmacist if the temperature goes out of range.
  • Immutable Logs: The records must be compliant with 21 CFR Part 11.

Deep Dive: What is 21 CFR Part 11?

This is one of the most misunderstood pieces of pharmacy regulation. 21 CFR Part 11 is the FDA’s rule for Electronic Records and Electronic Signatures. It dictates that if you use a computer system to store data that is required by law (like temperature logs or electronic D-Logs), that system must have specific features to be trustworthy.

Your temperature monitoring system is a legal record. Therefore, it must be 21 CFR Part 11 compliant. What does this mean in practice?

An uncalibrated probe means the temperature it’s reading might be wrong. If the probe is off by 3 degrees, your 8°C fridge could actually be 11°C.
21 CFR Part 11 Requirement What It Actually Means Why It Matters (The “Fail” Scenario)
Secure, Immutable Logs The log file generated by the system (the list of temperatures) cannot be changed. No one (not even an admin) can go in and delete the record from 3 AM when the fridge went to 10°C. A simple Excel log fails this. You could just type over the bad number. An auditor would reject this data instantly, and all drugs in that fridge would be considered adulterated.
Detailed Audit Trail The system must have a separate, background log that records every single action. (e.g., “User J. Smith logged in at 9:02 AM.” “User J. Smith acknowledged alarm at 9:03 AM.”) If someone *could* change a setting (like an alarm threshold), the audit trail would capture it. This proves no one is “cooking the books” to hide an excursion.
User-Specific Access Each user must have a unique username and password. You cannot have a shared “pharmacy” login. This links every action to a specific, trained person. A shared login means you have no idea who acknowledged an alarm or changed a setting. The entire system’s data is now unreliable.
System Validation The vendor must provide documentation proving the software works as intended and is secure. The probes (thermometers) must be calibrated (usually annually).
Practical Guide: The Temperature Excursion (TE) Masterclass

Scenario: It’s Monday at 8 AM. You check the 21 CFR Part 11 system for your 2°C-8°C refrigerator. You see a high-priority alarm. On Saturday at 11:30 PM, the temperature rose to 9.5°C for 2 hours due to a door not being fully latched. It then returned to normal. You have 50 kits for 4 different studies in that fridge.

This is the moment that defines an IDS pharmacist. Follow this protocol precisely.

  1. STEP 1: CONTAINMENT. Do not touch or dispense anything from that refrigerator. Place a large, physical sign on the door: “DO NOT USE – QUARANTINED. POSSIBLE TEMPERATURE EXCURSION. CONTACT IDS PHARMACIST – [Your Name/Number].”
  2. STEP 2: GATHER DATA. Log into the 21 CFR 11 system. Export the *entire* temperature log for that refrigerator, not just the excursion period. You need to show it was stable *before* and *after*. Note the following:
    • Exact time the temperature first went above 8.0°C.
    • Exact time it returned to 8.0°C or below.
    • The *total* duration of the excursion (e.g., “2 hours and 14 minutes”).
    • The *peak* temperature reached (e.g., “9.5°C”).
  3. STEP 3: IDENTIFY PRODUCT. Create a list of every single kit in that refrigerator, organized by protocol. (e.g., “Protocol ACME-101: 20 kits, Lot #ABC”, “Protocol BETA-202: 30 kits, Lot #XYZ”).
  4. STEP 4: NOTIFY. (CRITICAL) You must immediately notify the sponsor (or their designated CRA/Monitor) for *each* affected protocol. This is not your decision to make. Send a formal email with all the data you gathered.
    Script: “Dear [CRA Name], This is a formal notification of a temperature excursion for Protocol ACME-101. On [Date], our 2-8°C refrigerator had an excursion… [list all data from Step 2]. A list of all affected IP is attached. All product has been quarantined. Please advise on product stability and disposition.”
  5. STEP 5: AWAIT DISPOSITION. The sponsor’s stability team will now review their internal data. You will wait for a formal, written response. This response is called the “disposition.” It will be one of two things:
    • a) “Product is Stable”: “We have stability data for Acme-Drug-X at 10°C for up to 24 hours. The product is considered viable. Please remove from quarantine and return to stock.”
    • b) “Product is Adulterated”: “This excursion exceeds our stability profile. The product is considered non-viable and must be destroyed. Please continue to quarantine for destruction. We will arrange a replacement shipment.”
  6. STEP 6: DOCUMENT & TRANSACT. This is the final step. You must print the excursion log, your email to the sponsor, and their official disposition. You file this in your protocol binder.
    • If disposition is “Stable,” you remove the sign and you’re done.
    • If disposition is “Adulterated,” you must update your Drug Accountability Log. You make a new entry: “Date: [Today’s Date], Transaction: ‘Quarantined for Destruction due to TE #2025-01’, Units Out: [All 20 kits], Balance: 0. See comments.” The kits are then moved to a separate “Destruction” bin to await final reconciliation.

21.2.4 Masterclass: Dispensing and Blinding Protocols

The act of dispensing an investigational product is the most sacred part of your operational duties. It is a rigid, multi-step process designed to protect the patient and, critically, to protect “the blind”—the single most important scientific control in a Phase III trial.

The Dispensing Pre-Flight Checklist

You cannot dispense an IP just because a prescription appears. As a delegated investigator, you are the final checkpoint. You must verify all of the following before you even think about logging into the IWRS.

  1. Is the pharmacist on the DOA Log? (Are *you* delegated to dispense?)
  2. Is there a valid, signed prescription from the PI (or a delegated prescriber)?
  3. Is the patient still active in the study? (Has the coordinator confirmed their visit is happening today?)
  4. Has the patient’s signed Informed Consent Form (ICF) been verified? (Usually done at Visit 1, but you must know it’s on file).
  5. Are all pre-dispensing labs/checks complete? (e.g., “Must have pregnancy test on file,” “Must have SCr < 1.5"). The protocol will specify this.
The “Brain” of the Trial: The IWRS/IVRS

Once you clear the pre-flight check, you do not just “pick a drug.” You must consult the Interactive Web Response System (IWRS) (or its phone-based predecessor, IVRS). This is the centralized, sponsor-controlled computer system that manages randomization and the drug supply.

Tutorial: A Standard IWRS Dispensing Event

  • Step 1: Log In. You log into the secure IWRS web portal for that specific protocol.
  • Step 2: Identify Patient. You enter the patient’s unique Subject ID (e.g., “001-002”).
  • Step 3: Identify Visit. You select the current protocol visit (e.g., “Visit 3, Day 28”).
  • Step 4: Confirm Patient Status. You may have to check a box: “I confirm Subject 001-002 is present and eligible to be dispensed per protocol.”
  • Step 5: Receive Assignment. You click “Submit.” The IWRS, which holds the secret randomization code, thinks for a moment. It checks its inventory of kits at your site and its secret code. The screen then displays:
    “ASSIGN KIT # K-1008 FOR SUBJECT 001-002.”
  • Step 6: Pick and Verify. You go to your secure inventory, find Kit #K-1008, and physically verify the number. You then confirm in the IWRS: “I have picked Kit #K-1008.”
  • Step 7: Transact and Dispense. The IWRS now logs this assignment. You immediately go to your paper D-Log and make the entry for dispensing Kit #K-1008 to Subject 001-002. The dispensing event is now complete and auditable.

Maintaining the Blind: The Pharmacist’s Duty

In a double-blind trial, neither the patient nor the PI/staff knows who is getting the active drug versus the placebo. In most of these trials, you, the pharmacist, are also blinded.

The sponsor goes to incredible lengths to make this possible:

  • Identical Appearance: The active drug and the placebo tablet are manufactured to be identical in size, shape, color, and even taste.
  • Identical Packaging: The bottles, labels, and boxes are identical.
  • Blinded Labels: The label will not say “Lisinopril 10mg.” It will say: “Protocol ACME-505. For Investigational Use Only. 1 tablet PO daily.”
  • Numbered Kits: As described above, the IWRS just tells you to dispense “Kit #K-1008.” You have no idea if that kit contains the active drug or the placebo. You are just a cog in the blinding machine.

The “Unblinded” or “Open-Label” Pharmacy Role

What if the trial can’t be blinded?

  • Open-Label Trials: Sometimes, a trial is “open-label,” meaning everyone knows the patient is getting the active drug. This is common in Phase I safety studies or for life-saving oncology drugs where a placebo would be unethical.
  • The Unblinded Pharmacist: This is a more complex scenario. Imagine a trial comparing an IV drug (Drug A) to an oral drug (Drug B). To maintain the blind, you must use a “double-dummy” design. Every patient gets *both* an IV infusion and an oral tablet.
    • Group 1: Gets an Active IV + Placebo Tablet.
    • Group 2: Gets a Placebo IV + Active Tablet.

    The PI and patient can’t tell which is active. But who prepares the IV? A pharmacist. That pharmacist must be “unblinded” to know whether to draw up the active drug or the placebo (saline). In this model, the SP may have one or two designated “unblinded” pharmacists who are firewalled from the rest of the trial team. They prepare the IV, label it with only the kit number, and pass it out to the “blinded” nurse for administration. This unblinded pharmacist can have no contact with the patient or the PI about the study.

Practical Guide: The Emergency Unblinding Protocol

Scenario: Your patient, Subject 001-002, is on the blinded study. They are rushed to an outside ER with a severe, life-threatening arrhythmia. The ER doctor calls the PI and says, “I don’t know what they’re on, and I need to know *now* to treat them.”

You, the pharmacist, almost never unblind the drug. The power rests with the PI and the IWRS.

  1. The Principal Investigator (PI) makes the medical judgment that unblinding is necessary for the patient’s immediate safety.
  2. The PI (or a delegated coordinator) logs into the IWRS portal. There is a “red button” function: “Emergency Unblinding.”
  3. The PI must enter a reason (e.g., “Subject SAE, acute arrhythmia, essential for clinical management”).
  4. The PI clicks “Submit.” The IWRS then reveals the treatment assignment *for that subject only*. (e.g., “Subject 001-002 is in the Placebo Arm.”)
  5. The PI can now tell the ER doctor. This event is automatically logged by the IWRS and an alert is sent to the sponsor.
  6. Your Role (The Pharmacist): The PI must notify you. You then must go into your records and make a note: “Per PI notification, Subject 001-002 was unblinded on [Date] due to SAE. Patient was in Placebo Arm.” This patient is now “unblinded” and will likely be removed from the primary analysis of the study, but must still be followed for safety.

21.2.5 The Masterclass: Investigational Drug Accountability (The D-Log)

This is the single most important, error-intolerant, and audited function of an IDS pharmacy. It is the direct answer to 21 CFR 312.62. The Drug Accountability Log (D-Log), also called a Drug Accountability Record (DAR), is the master ledger that provides a chain of custody for every single dosage unit (tablet, capsule, vial) from “cradle to grave.”

The #1 Mantra of Drug Accountability: “A disposition for every dosage unit.”

This means that if the sponsor ships you 1,000 tablets, your final logs must be able to show an auditor *exactly* where all 1,000 of those tablets went. The math must be perfect. (Dispensed) + (Returned) + (Destroyed) + (On-Hand) MUST EQUAL (Received).

Most D-Logs are still paper, as this is often considered the most durable and auditable “source document.” Electronic D-Log systems exist, but they must be 21 CFR Part 11 compliant.

Anatomy of a “Gold Standard” Drug Accountability Log

A separate, dedicated log must be kept for each combination of Protocol, Drug, Strength, and Lot Number.

Drug Accountability Log – PROTOCOL: ACME-101
Site #:123PI:Dr. James Wilson
IP Name:Acme-Drug-XStrength:10 mg
Dosage Form:TabletLot #:Lot-ABC-001
Date Transaction Type
(Received, Dispensed, Returned, etc.)		 Subject ID / Shipment # Kit ID(s) Units In Units Out Balance Pharmacist Initials
10/20/25 Received from Sponsor SH-1001 / Fedex 123 K-1001, K-1002, K-1003 90 90 JPS
10/22/25 Dispensed to Subject (Visit 1) 001-001 K-1001 30 60 PRJ
10/23/25 Dispensed to Subject (Visit 1) 001-002 K-1002 30 30 JPS
10/24/25
GCP CORRECTION:

Entry on 10/23/25 for 001-002 was in error. Kit K-1002 was not dispensed. See Comments. – JPS 10/24/25
10/24/25 DISPENSING – CORRECTED ENTRY 001-002 K-1003 30 0 JPS
10/24/25 ERROR CORRECTION – PER COMMENT 001-002 K-1002 30 30 JPS
10/28/25 Received from Sponsor SH-1002 / Fedex 456 K-1004 30 60 PRJ
11/19/25 Returned from Subject (Visit 2) 001-001 K-1001 (2 pills returned) (N/A) (N/A) 60 JPS

Deconstructing the D-Log Transactions:

  • Receiving: When a shipment arrives, you verify it against the packing list and the temperature monitor (if any). You create a new entry. “Units In” increases the balance. This log must be traceable to the shipping invoice.
  • Dispensing: This is a “Units Out” transaction. You must record the Subject ID and the specific Kit ID assigned by the IWRS.
  • The GCP Correction: This is CRITICAL. You NEVER use white-out or scribble out an error. You draw a single, thin line through the error, write the correction, then initial, date, and (ideally) add a comment explaining *why*. Look at the example on 10/24/25. The pharmacist (JPS) dispensed the wrong kit (K-1002), realized the error, crossed it out, and then made *two new entries* to fix it: one to dispense the *correct* kit (K-1003) and one to “receive” Kit K-1002 back into the investigational stock. This is a perfect, auditable correction.
  • Patient Returns (“Reverse Logistics”): This is a key confusion point. When a patient returns a bottle (e.g., on 11/19/25), it does not change your “Balance” of usable stock. Those 2 returned pills are now “used” and must be logged on a *separate* D-Log for “Returned/Quarantined Product.” The entry on the main log is just a note that the return occurred. The physical pills are moved to a separate quarantine bin. Your total accountability is now: 60 (on hand) + 30 (dispensed K-1003) + 2 (returned K-1001) = 92. Wait… this doesn’t add up. Why?

    Ah! The log must be clearer. The transaction for a return should be on a separate log. The entry on 11/19/25 should simply be a comment. The *true* accountability is:
    Total Received: 90 (K1-3) + 30 (K4) = 120 units
    Total Dispensed: 30 (K1 to 001-001) + 30 (K3 to 001-002) = 60 units
    On-Hand Balance: 30 (K2) + 30 (K4) = 60 units
    Equation: 120 (Received) = 60 (Dispensed) + 60 (On-Hand). The math works.
    The 2 pills returned by 001-001 are documented separately as part of the adherence check and are quarantined for destruction.

21.2.6 Audits, Monitoring, and the Role of the CRA

Your perfect records mean nothing if they aren’t verified. This verification is the job of the Clinical Research Associate (CRA), also known as a “monitor.” This individual is hired by the sponsor to be their eyes and ears. Their entire job is to conduct Source Document Verification (SDV)—comparing your source documents (D-Logs, temp logs) to the data entered in the trial database.

The Types of “Visits” You Will Experience
  • Site Initiation Visit (SIV): Before the trial starts. The CRA comes to your pharmacy, inspects your facility, and trains you and your staff on the protocol, the D-Logs, and the storage requirements. You must be “activated” by the CRA before they will ship you any drug.
  • Interim Monitoring Visit (IMV): These happen every 4-8 weeks during the trial. This is the “audit.” The CRA will sit in your office and say, “Show me everything.”
  • Close-Out Visit (COV): The trial is over. The CRA comes for the final time to do a 100% reconciliation of every pill. They will oversee the final destruction or return of all remaining IP. They will ensure all logs are signed, dated, and complete before being archived (often for 15+ years).
Pharmacist Practical Guide: Surviving an IMV (The Audit)

A monitor is not your enemy; they are your collaborator. Their job is to find and fix errors *before* the FDA does. Here is their pharmacy checklist:

  1. 1. The D-Log Reconciliation: They will start here. They will take your paper D-Logs and reconcile them against the IWRS system and the dispensing records in the patient’s chart. They are looking for a 100% match.
    Pro Tip: Reconcile your *own* logs *before* the monitor arrives. This is called “Internal QA.” Find and fix your own mistakes first.
  2. 2. The Physical Count: They will ask you to open the fridge/cabinet and they will physically count your on-hand inventory. The physical count must match the “Balance” column on your D-Log.
  3. 3. The “Returned” Count: They will also count the quarantined, returned patient medication to ensure that log is also accurate.
  4. 4. Temperature Log Review: They will ask for your temperature logs (electronic or paper) covering the entire period since their last visit. They are looking for two things:
    • Any excursions.
    • If there *was* an excursion, they will demand to see the full documentation (your notification, the sponsor’s disposition).
  5. 5. The DOA Log Review: They will take your D-Logs and compare the “Pharmacist Initials” column against the Delegation of Authority Log. They are verifying that every person who handled the drug was actually trained and delegated to do so.
    Common Finding: A new “floater” pharmacist helped out, signed a log, but was never added to the DOA. This is a major finding.

What is a “Query”? When the CRA finds an error (e.g., a missing date on a log), they will issue a “query” or “action item.” This is a formal request to fix the error. You must address it using the GCP correction method (single line-through, initial, date, explain). You then sign off on the query, and the monitor closes it. Your goal is to have zero queries.

The “Audit” vs. The “Inspection”

These two words are terrifying but very different.

  • Sponsor Audit (IMV): This is your friend (a demanding one). They are from the sponsor, and you work *with* them to ensure the data is clean. It’s a quality check.
  • FDA Inspection: This is the Super Bowl. This is the government. They are not there to collaborate; they are there to inspect. They have the force of law. If your site is chosen for an inspection (usually because the data is *very* important for a new drug approval), the FDA inspector will do everything the CRA did, but with a badge. Your perfect, CRA-audited records are your only defense.

21.2.7 Conclusion: The IDS Pharmacist as Guardian

The Investigational Drug Service is the functional, regulated heart of a clinical trial site. It is a pharmacy where the primary products are not just drugs, but safety and data. Your retail and specialty pharmacy skills—precision, patient-focus, and workflow management—are the essential prerequisites for this role.

However, the IDS pharmacist adds an inflexible layer of regulatory compliance. You are the on-site expert in 21 CFR 312 and GCP. You are the guardian of the Delegation of Authority Log. You are the master of the 21 CFR Part 11 temperature system. You are the high priest of the Drug Accountability Log, ensuring a perfect reconciliation for every dosage unit.

You are the professional who builds and maintains the “vault,” ensuring that the scientific question being asked by the trial can be answered with data that is clean, accurate, and, above all, indisputable. This is one of the most challenging, and most rewarding, applications of advanced pharmacy practice.