Certified Clinical Trials Pharmacist (CCTP)

CCTP (CTP-001) Exam Objectives

This exam certifies that the candidate has the clinical skills and regulatory knowledge to provide safe and effective pharmaceutical care to patients participating in clinical trials.

Domain 1: Clinical Trial Conduct and Good Clinical Practice (GCP) (25%)

• Informed Consent: Describe the pharmacist's role in the informed consent process, particularly in explaining the investigational drug regimen.
• GCP for Clinical Practice: Apply the principles of ICH-GCP (E6) to daily clinical practice, focusing on patient safety and data integrity.
• Protocol Adherence: Implement strategies to ensure strict adherence to all aspects of the clinical trial protocol.

Domain 2: Protocol-Specific Patient Management (40%)

• Patient Education: Develop and provide comprehensive education to study subjects on the investigational product, including administration, potential side effects, and storage.
• Therapeutic Monitoring: Monitor patients for efficacy and toxicity according to the protocol-defined schedule of assessments.
• Adverse Event Management: Identify, assess, and manage adverse events experienced by study subjects, including dose modifications as allowed by the protocol.
• Concomitant Medication Management: Review and manage patients' non-study medications to prevent interactions that could affect study results or patient safety.

Domain 3: Investigational Product Management (at the clinic level) (25%)

• Dispensing and Accountability: Dispense investigational products accurately and maintain accountability records at the clinic level.
• Patient Adherence: Assess and promote patient adherence to the investigational product regimen.
• Product Handling: Counsel patients on the proper handling, storage, and return of their study medication.

Domain 4: Data Collection and Patient Safety Reporting (10%)

• Source Documentation: Accurately document all patient interactions and clinical findings in the research record.
• Adverse Event Reporting: Report adverse events and serious adverse events to the study sponsor and IRB within the protocol-specified timelines.

Eligibility Requirements

To be eligible to sit for a CPS certification exam, candidates must meet the criteria outlined in one of the two pathways below.

Pathway 1: For U.S. Licensed Pharmacists

This pathway is for pharmacists licensed to practice within the United States, regardless of country of graduation.

• Hold an active and unrestricted pharmacist license in any state or territory of the United States.
• Meet educational requirements by being a graduate of an ACPE-accredited school of pharmacy or holding a Foreign Pharmacy Graduate Examination Committee® (FPGEC) Certificate.
• Fulfill the specialty experience requirement as outlined below.

Pathway 2: For International Pharmacists (Non-U.S. Licensed)

This pathway is for pharmacists who practice outside of the United States.

• Hold an active and unrestricted license to practice pharmacy in their country of practice. A certified English translation of the license must be provided if the original is not in English.
• Hold a professional degree in pharmacy equivalent to a U.S. pharmacy degree, such as a Bachelor’s degree (BPharm), Master’s degree in Pharmacy Practice (MPharm), or Doctor of Pharmacy degree (PharmD).
• Fulfill the specialty experience requirement as outlined below.

Specialty Experience Requirement (for all pathways)

To ensure candidates have foundational knowledge in the specialty, one of the following criteria must be met:

• Standard Pathway:
  Completion of at least one year of professional experience in a practice setting directly related to the certification area.
• Certificate Pathway:
  The one-year specialty experience requirement is waived for candidates who hold an active certificate of completion from a nationally recognized provider in a related subject matter. This includes, but is not limited to, the completion of a relevant PGY residency, fellowship, certificate/training program, or a relevant graduate degree (e.g., a Master's degree in the specialty field). Recognized providers of certificate programs include, but are not limited to:
  • American Society of Health-System Pharmacists (ASHP)
  • American Pharmacists Association (APhA)
  • American College of Clinical Pharmacy (ACCP)
  • American Society of Consultant Pharmacists (ASCP)

Career Path for CCTP Professionals

The CCTP certification is for pharmacists who are directly involved in patient care within a clinical trial. This is a highly sought-after role in academic medical centers, cancer centers, and large physician practices with active research programs.

Target Candidates

• Pharmacists with residency training, particularly in oncology or ambulatory care.
• Clinical pharmacists working in academic medical centers or research-intensive clinics.
• Pharmacists with prior experience in an Investigational Drug Service (IDS) seeking a more patient-facing role.

Primary Job Roles:

• Clinical Research Pharmacist
• Ambulatory Care Pharmacist (in a research-heavy clinic)
• Oncology Clinical Pharmacist (with research duties)
• Clinical Trial Navigator

Career Advancement:

A CCTP can advance to become a senior research pharmacist or clinical coordinator for a large portfolio of trials. Their deep clinical and protocol-level expertise also makes them strong candidates for roles in the pharmaceutical industry, such as a Clinical Scientist or Medical Science Liaison.

Study Resources

Prepare for your CCTP exam with resources focused on the unique clinical demands of managing patients in a research study.