CIDSP Exam Content Outline

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Certified Investigational Drug Services Pharmacist (CIDSP)

Official Examination Content Outline

This document provides the official content outline for the Certified Investigational Drug Services Pharmacist (CIDSP) examination. The exam certifies that a pharmacist possesses the specialized expertise to manage investigational drug products for human clinical trials, ensuring the integrity of the research, the safety of human subjects, and compliance with all regulatory and ethical standards.

Examination Specifications

Name of Credential Certified Investigational Drug Services Pharmacist (CIDSP)
Certification-Issuing Body The Council on Pharmacy Standards (CPS)
Designation Awarded CIDSP
Target Population Pharmacists who are integral members of clinical research teams in academic medical centers, hospitals, and industry.
Examination Length 120 multiple-choice items
Administration Time 3.0 hours

Examination Content Outline

The CIDSP examination is weighted according to the five domains listed below, covering the entire lifecycle of a clinical trial from a pharmacy perspective, from study start-up and regulatory compliance to final close-out and audits.

Domain 1: Regulatory Compliance and Study Start-Up 25%
Domain 2: Investigational Product (IP) Management and Logistics 30%
Domain 3: Clinical Trial Conduct and Participant Safety 20%
Domain 4: Documentation, Audits, and Financial Management 20%
Domain 5: Leadership, Education, and Innovation 5%

Domain 1: Regulatory Compliance and Study Start-Up (25%)

Task 1: Implement global and federal regulations for clinical research.
  • Apply the principles of ICH GCP E6(R3), including risk-proportionate approaches and quality-by-design.
  • Interpret and apply FDA regulations (e.g., 21 CFR Parts 11, 50, 56, 312) governing human subjects and electronic records.
  • Differentiate the regulatory responsibilities of the sponsor, investigator, and Institutional Review Board (IRB).
  • Manage trial registration and results reporting on public registries (e.g., ClinicalTrials.gov, CTIS).
Task 2: Evaluate clinical trial protocols for feasibility and safety.
  • Analyze the medication-related sections of a draft protocol for clinical and operational feasibility.
  • Assess the complexity of the protocol's medication preparation, dispensing, and administration requirements.
  • Evaluate the adequacy of institutional resources to safely conduct the trial.
  • Provide expert feedback to the principal investigator and study sponsor on the protocol's pharmacy manual.
Task 3: Manage IRB and other regulatory submissions.
  • Manage pharmacy-related documents for IRB submissions, including initial reviews, amendments, and continuing reviews.
  • Ensure the informed consent form (ICF) accurately describes all medication-related procedures and risks.
  • Manage the Investigational New Drug (IND) application process for investigator-initiated trials.
  • Report unanticipated problems involving risks to subjects or others to the IRB and sponsor.
Task 4: Manage site initiation and activation procedures.
  • Lead the feasibility assessment and budget development for the pharmacy components of a new trial.
  • Participate in site qualification and initiation visits to represent the pharmacy's capabilities.
  • Develop and implement study-specific pharmacy standard operating procedures (SOPs).
  • Ensure all required contracts and agreements are in place before study activation.
Task 5: Design study-specific pharmacy procedures and tools.
  • Translate protocol requirements into detailed, step-by-step procedures for IP handling.
  • Create study-specific order sets and medication records within the electronic health record (EHR).
  • Develop comprehensive worksheets for the preparation and dispensing of the investigational product.
  • Develop clear instructions for nurses on the proper administration of the IP.
Task 6: Implement a risk-based monitoring (RBM) plan.
  • Contribute to the development of a risk-based monitoring plan for the trial.
  • Identify high-risk pharmacy processes that require more intensive monitoring.
  • Utilize remote monitoring platforms and centralized data review to oversee trial conduct.
  • Implement quality-by-design (QbD) principles in IDS operations.

Domain 2: Investigational Product (IP) Management and Logistics (30%)

Task 1: Manage IP procurement, receipt, and inventory.
  • Oversee the ordering, receipt, and quarantine of all investigational products.
  • Implement and manage a robust temperature monitoring program, including documentation of excursions using validated digital systems.
  • Manage the IP resupply process to ensure an adequate supply is always on hand.
  • Ensure compliance with all import/export regulations for international trials.
Task 2: Manage the preparation of sterile and non-sterile IPs.
  • Apply USP <797>, <795>, and <800> standards to the compounding of IPs.
  • Implement a robust quality assurance process, including independent double-checks, for all compounded IPs.
  • Manage the preparation of placebos and comparator agents.
  • Ensure the stability and appropriate beyond-use dating of all prepared IPs.
Task 3: Manage advanced therapy investigational products (ATIMPs).
  • Implement handling procedures for cell and gene therapies, biologics, and other advanced modalities.
  • Manage unique storage requirements, such as cryopreservation, and chain of identity.
  • Oversee complex preparation processes, including thawing and bedside verification.
  • Ensure compliance with FACT-JACIE standards where applicable.
Task 4: Manage IP dispensing, randomization, and blinding.
  • Utilize Interactive Response Technology (IRT) systems to manage randomization and drug assignment.
  • Implement and maintain rigorous procedures to protect the study blind at all times.
  • Develop and follow a formal procedure for emergency unblinding when medically necessary.
  • Label all IPs with the required information according to regulatory standards.
Task 5: Manage IP accountability, reconciliation, and disposition.
  • Maintain complete, accurate, and contemporaneous drug accountability records for each protocol.
  • Perform regular reconciliations of the physical inventory against the accountability records.
  • Investigate and resolve any discrepancies in a timely and documented manner.
  • Manage the return or destruction of all used and unused IP at study close-out.
Task 6: Implement IP logistics for decentralized clinical trials (DCTs).
  • Design protocols for direct-to-participant shipping and home delivery of IP.
  • Ensure cold chain integrity is maintained during transport and at remote storage locations.
  • Utilize technology for remote monitoring of IP storage conditions and participant adherence.
  • Manage IP accountability in a decentralized trial environment.

Domain 3: Clinical Trial Conduct and Participant Safety (20%)

Task 1: Evaluate medication-related eligibility criteria.
  • Analyze a potential participant's medication history against the protocol's inclusion/exclusion criteria.
  • Identify any prohibited concomitant medications or contraindications that would exclude a participant.
  • Communicate medication-related eligibility concerns to the principal investigator and research coordinator.
  • Assess the participant's ability to adhere to the study medication regimen.
Task 2: Implement the informed consent process.
  • Explain the medication-related aspects of a clinical trial to potential participants.
  • Answer any questions a participant may have about the investigational product, its risks, and its alternatives.
  • Verify that the participant has provided voluntary, informed consent before any study procedures begin.
  • Manage the eConsent process in virtual or decentralized trials.
Task 3: Manage participant education and adherence.
  • Provide detailed counseling on the proper use, storage, and administration of the investigational product.
  • Educate the participant on the use of any study-specific digital health tools (e.g., ePRO, wearables, adherence apps).
  • Implement strategies to monitor and promote participant adherence to the IP regimen.
  • Use the teach-back method to confirm the participant's understanding of key information.
Task 4: Manage a participant's concomitant medications.
  • Perform a thorough medication reconciliation at each study visit.
  • Identify and manage any potential drug-drug interactions between the IP and concomitant medications.
  • Provide guidance to the participant and their other providers on which medications are permitted by the protocol.
  • Document all concomitant medications accurately in the source records.
Task 5: Evaluate and manage adverse events and toxicities.
  • Recognize, assess, and grade adverse events (AEs) and serious adverse events (SAEs).
  • Assess the causality of an adverse event to determine its relationship to the investigational product.
  • Collaborate with the sponsor's pharmacovigilance team to ensure timely and accurate safety reporting.
  • Implement protocol-specified dose modifications or supportive care to manage toxicities.
Task 6: Implement strategies to enhance diversity and inclusion.
  • Contribute to the development of recruitment and retention strategies for underrepresented populations.
  • Ensure that participant-facing materials are culturally competent and available in appropriate languages.
  • Address potential barriers to trial participation related to social determinants of health.
  • Ensure compliance with FDA and NIH guidelines on diversity in clinical trials.

Domain 4: Documentation, Audits, and Financial Management (20%)

Task 1: Manage study documentation and data integrity.
  • Maintain a complete and organized pharmacy file for each clinical trial, including the electronic Trial Master File (eTMF).
  • Ensure that all source documents are compliant with ALCOA-C principles.
  • Enter and manage pharmacy-related data in clinical trial technology systems (e.g., EDC, CTMS).
  • Respond to data queries from the study sponsor or data management team in a timely manner.
Task 2: Manage monitoring visits, audits, and inspections.
  • Prepare all pharmacy documentation in advance of a monitoring visit, audit, or inspection.
  • Host monitors, auditors, and regulatory inspectors and facilitate their review of pharmacy records.
  • Develop and implement a formal corrective and preventive action (CAPA) plan in response to audit findings.
  • Foster a culture of audit readiness and continuous quality control.
Task 3: Manage data and safety monitoring activities.
  • Prepare and provide data on drug exposure, dosing, and adverse events for safety reviews.
  • Contribute to the preparation of reports for the Data and Safety Monitoring Board (DSMB).
  • Manage the reconciliation and reporting of serious adverse events (SAEs) to the sponsor and IRB.
  • Analyze dispensing and accountability data to ensure the integrity of the trial.
Task 4: Manage research billing compliance.
  • Differentiate between medications and services billable to the study sponsor versus the participant's insurance.
  • Contribute to the development of a Medicare Coverage Analysis (MCA) for all study-related items and services.
  • Ensure that investigational products are not billed to the participant or their insurer.
  • Collaborate with the research billing and finance departments to prevent billing errors.
Task 5: Manage financial performance of the Investigational Drug Service (IDS).
  • Develop a standardized fee schedule for IDS services.
  • Negotiate the pharmacy budget with the study sponsor during study start-up.
  • Track all billable events and manage sponsor invoicing and milestone tracking.
  • Conduct periodic reviews to ensure the IDS is financially sustainable and recovering costs.
Task 6: Manage expanded access programs.
  • Differentiate between various types of expanded access programs (e.g., single patient IND, intermediate-size).
  • Manage the receipt, storage, and accountability of compassionate use investigational products.
  • Collaborate with the clinical team and IRB to ensure all regulatory requirements are met.
  • Ensure proper billing and cost recovery for expanded access treatments.

Domain 5: Leadership, Education, and Innovation (5%)

Task 1: Evaluate and implement new technologies.
  • Assess new technologies for their potential to improve the safety and efficiency of IDS operations.
  • Lead the implementation and validation of new software and automation.
  • Develop training programs for staff on new technologies.
  • Stay current with innovations in pharmacy research technology.
Task 2: Implement training and professional development programs.
  • Serve as a preceptor for pharmacy students and residents on IDS rotations.
  • Provide ongoing education to pharmacy staff on clinical research principles and regulations.
  • Educate nurses, physicians, and research coordinators on medication-related aspects of clinical trials.
  • Present on investigational drug services at institutional or professional meetings.
Task 3: Implement quality improvement initiatives.
  • Lead or participate in quality improvement projects to enhance the safety and efficiency of the IDS.
  • Develop and monitor key performance indicators (KPIs) for IDS operations.
  • Use quality improvement methodologies (e.g., PDSA, Lean) to drive process improvements.
  • Foster a culture of continuous quality improvement within the IDS team.
Task 4: Manage interprofessional teams and relationships.
  • Serve as the primary liaison between the IDS and the broader research community (e.g., investigators, coordinators).
  • Lead multidisciplinary teams including pharmacy, nursing, and regulatory personnel on research initiatives.
  • Participate in institutional research oversight committees.
  • Advocate for the role of the pharmacist in the clinical research enterprise.
Task 5: Document and manage IDS policies and procedures.
  • Develop and maintain a comprehensive set of standard operating procedures (SOPs) for the IDS.
  • Establish a process for the periodic review and updating of all SOPs.
  • Ensure that all IDS practices are consistent with the written SOPs.
  • Maintain all SOPs in a controlled and readily accessible format.
Task 6: Contribute to the advancement of research pharmacy practice.
  • Participate in professional organizations related to research pharmacy.
  • Contribute to the medical literature through scholarly activity, such as publications or presentations.
  • Mentor junior staff and trainees interested in a career in research pharmacy.
  • Develop innovative solutions to common challenges in investigational drug management.

Next Steps

Key Reference Standards

While the examination assesses a broad range of knowledge, candidates may find it helpful to be familiar with the principles and standards from the following sources:

  • ICH GCP E6(R3): Good Clinical Practice
  • FDA 21 CFR Part 11: Electronic Records; Electronic Signatures
  • FDA 21 CFR Part 50: Protection of Human Subjects
  • FDA 21 CFR Part 56: Institutional Review Boards
  • FDA 21 CFR Part 312: Investigational New Drug Application
  • NIH Policies and Guidelines on the Inclusion of Women and Minorities
  • ISPE/GMP Guidelines for Investigational Medical Products