Statement of Scope: ACRP Certification Exams

Overall Scope of the Examinations

The ACRP/APPI certification examinations are the formal recognition of clinical research professionals who have met the professional eligibility requirements and demonstrated job-related knowledge and skills. Certification is granted in recognition of documented and verified work experience and after successful performance on a multiple-choice exam.  The examinations are relevant for all research studies involving human subjects, including but not limited to drug, device, and biologic studies.

Core Examination Content

All ACRP and APPI examinations have as their core the requirements of Good Clinical Practice as identified by the International Conference on Harmonisation (ICH) guidelines.  These guidelines form the basis of the conduct of human clinical research worldwide.  The specific core requirement documents that form the basis for all examinations are: 

• ICH Good Clinical Practice: Consolidated Guideline (E6)
• ICH Clinical Safety Data Management : Definitions and Standards for Expedited Reporting (E2A)
• ICH General Considerations for Clinical Trials (E8)
• Declaration of Helsinki

Regional Examination Supplemental Content

In North America, the ACRP examinations use the core requirements as the basis and include specific questions that relate to the Food and Drug Administration the following regulations, forms, and guidances:

• 21 CFR 10.90, 11, 50, 54, 56, 312, 314, 316, 320, 330, 601, 812, 814
• 45 CFR 46, 160, 164 (HIPAA Privacy & Security)
• Guidelines for the Monitoring of Clinical Investigations (January 1988)
• FDA Forms 1571, 1572, 482, 483, 3500A
• FDA information sheets (September 1998)
• FDA Compliance Program Guidance Manual 7348.809, 7348.810, and 7348.811
• General Considerations for the Clinical Evaluation of Drugs

In the European Union, the ACRP examinations use the core requirements as the basis and include specific questions that relate to the European Clinical Trial Directive 2005/28/EC

In non-North American and non-EU member states, the ACRP examinations use the core ICH requirements and the Declaration of Helsinki as the basis of all questions.  Individual country specific questions are not included because of the diversity of country-specific requirements and the considered opinion that the core requirements represent the relevant practice of clinical research requirements.                    

Functionally Specific Requirements

ACRP certifies clinical research professionals on the basis of specific job functions.  It is felt that offering job specific examinations provides higher value to the certificants than a more general approach.  ACRP examinations uniquely provide the demonstration of competence and proficiency in the application of recognized good clinical practices principles to a specific job function.

Clinical Research Associate (CRA): Assuring that the research site personnel, including the investigators, are conducting the study according to GCP guidelines.

• Assuring that all applicable regulatory requirements are being met by the investigator's site.
• Assuring that applicable adverse events are properly reported to the sponsor.
• Reviewing of site record accuracy regarding drug accountability.
• Clinical trial-related activities for the sponsor such as protocol development, site/investigator selection, study initiation activities, study termination activities, CRF processing/management activities (including in-house sponsor review and query resolution), final study report development, and supervision of other CRAs.

Clinical Research Coordinator (CRC): A CRC, regardless of job title, works at a clinical research site under the immediate direction of a principal investigator, whose research activities are conducted under Good Clinical Practice (GCP) Guidelines. CRCs typically perform tasks such as:

• Site preparation
• Patient screening and recruitment
• Patient enrollment
• Conducting study visits
• Maintaining and dispensing drug supplies
• Completing and ensuring the quality of case report forms
• Maintaining source documents
• Ensuring site quality

Clinical Trial Investigator (non-physician) (CTI): A Clinical Trial Investigator, regardless of job title, works at a clinical research site as the non-physician or unlicensed physician investigator whose research activities are conducted under Good Clinical Practices (GCP), FDA regulations and ICH guidelines. Clinical Trial Investigators perform, at a minimum, the following tasks:

• Evaluating the study proposal and decide on participation.
• Facilitating or verify formal approvals according to FDA and ICH-GCP and any applicable local requirements.
• Performing and/or supervising the conduct of study-related procedures and monitor the safety of the trial subjects and investigational staff.
• Collecting accurate and verifiable data and other essential study documents.
• Ensuring compliance with FDA and ICH-GCP, the protocol and any investigational product.
• Communicating with subjects, sponsor's personnel and IEC/IRB.

Additionally, Clinical Trial Investigators are responsible for:

• Ensuring that all site initiation activities are performed to start and conduct the study.
• Participating in the selection of trial subjects according to the recruitment strategy.
• Ensuring that study-related procedures are delegated only to individuals who are sufficiently trained/experienced.
• Ensuring adequate close-out of the study.

Physician Investigator: A physician investigator is a physician (M.D. or equivalent degree) with a current medical license to practice where the trials are being conducted and who serves as the primary, sub- or co-investigator or monitors, supervises, or designs clinical trials and accepts responsibility for the safe and ethical conduct of a clinical trial, herein defined as a systematic experiment designed to evaluate the pharmacokinetics, pharmacodynamics, pharmacoeconomics, safety, efficacy, and effectiveness of a drug, biological, medical device (therapeutic or diagnostic), procedure or other intervention involving human participants.Physician Investigators perform, at a minimum, the following tasks:     

• Responsible for the safe and ethical conduct of a clinical trial
• Evaluates the study proposal and decides on participation
• Facilitates or verifies formal approvals according to FDA and ICH GCP and local requirements
• Ensures that all site initiation activities are performed to start and conduct the study
• Participates in the selection of trial subjects according to the recruitment strategy
• Performs and/or supervises the conduct of study-related procedures and monitors the safety of the trial subjects and investigational staff
• Collects accurate and verifiable data and other essential study documents
• Ensures compliance with FDA and ICH GCP, the protocol and the handling of the investigational product
• Communicates with subjects, sponsor's personnel and IEC/IRB
• Ensures adequate close-out of the study

Eligibility Requirements

Experience: Since all ACRP examinations are based on the application of the clinical research knowledge base, ACRP requires a minimum of two years of experience in the job functions for the examination for which a candidate is applying. Job experience for CRAs and CRCs can be any time in their career as a clinical research professional. Physician and non-physician investigators must have experience in the previous two years of their application to take the certification examination.

Education: The educational requirements for CRCs is minimally a high school diploma or the equivalent. The educational requirements for CRAs is:

The educational requirements for CTIs is a Doctorate level degree or equivalent clinical research professional, e.g., PhD, PharmD, Doctorate in Nursing, Psychologists, licensed Physician Assistants and Nurse Practitioners who serve in an investigator role. Included are PhD's working in or for the pharmaceutical industry who supervise clinical investigators for clinical trial sponsors. The educational requirements for CPIs is a medical (M.D. or equivalent degree) and be in good standing with local, state, and national licensing and regulatory authorities and certifying bodies.