Beyond the Books: preparations to help achieve your CRA accreditation
Preparing for the CRA accreditation assessment offered by the IAOCR requires an understanding of clinical research fundamentals, regulations, and specific competencies. You should collect all relevant study materials, including textbooks, research articles, industry guidelines, and any provided by the IAOCR.
Whilst these should be foremost in your preparations for the assessment, there are further competencies and practices that you will need to draw on in order to fully demonstrate your abilities and to pass the assessment.
Understand the full CRA accreditation requirements
The IAOCR assessment will look at how you apply principles in the workplace and demonstrate the full range of competency in all the areas required, we’ve summarized 12 key competencies below and the expectations the assessment has on CRAs knowing how all of these come together.
Familiarize yourself with these areas and the professional standards that the accreditation covers. Understanding these criteria will help you tailor your preparation effectively.
Ethics and ICH-GCP
Upholding the ethical standards that clinical trials adehere to ensures that the rights and well-being of trial participants are protected, and that the clinical trial data is credible and accurate. The IAOCR assessment will review matters of trial integrity and adherence to International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines.
Legislation and regulation of clinical trials
The application of the regulatory requirements governing clinical research, will involve detailed documentation, regular audits, and proactive problem-solving to address any regulatory issues that arise. Documentary evidence of this activity forms the basis of a well regulated trial and your assessment application.
Rights and wellbeing of patients in a clinical trial
How do you maintain the rights of patients? CRAs must show adherence to conduct that maintains the wellbeing of patients. At the beginning, it is the collection of participants’ informed consent. As the trial continues, regular site visits and monitoring allow CRAs to review patient safeguarding protocols. Finally, the rights of patients demand the ethical handling of their data according to privacy laws and regulations.
Managing site and investigator relationships
How are you acting as the main point of contact between sponsor and trial site? Are you reporting on site visits, following up on issues that arise during a trial or troubleshooting a problem? Effective, proactive communication between stakeholders builds relationships and will reflect on your professionalism and ability to manage as a CRA.
Site management
Site compliance with regulatory requirements and study protocols starts with selecting the site then initiation. Noting the training of site staff, or ongoing monitoring or responsibilities, show that a site is being very precisely managed. And at the closeout of the site, the CRA needs to show that all data is collected, regulatory documents are completed, and the site is prepared for audit.
Pharmacovigilance
To practice pharmacovigilance, the CRA needs to maintain a robust system for signal detection and risk management. Serious adverse events (SAEs) must be reported accurately and in a timely manner especially suspected unexpected serious adverse reactions (SUSARs). And safety data should be safely stored and analyzed.
How are you, the CRA, managing the detection, assessment, understanding, and prevention of these drug-related problems? Ad how can that be shown in your CRA accreditation assessment?
Data management
Data management is critical to ensure the integrity and reliability of clinical trial results. CRAs are responsible for ensuring that data is collected in compliance with the study protocol and regulatory requirements. Overseeing data collection and entry, and installing validation processes help ensure high-quality data management.
The key principles of data management include data accuracy, consistency, and completeness. Reviewing case report forms (CRFs), resolving data queries, and ensuring timely data entry will contribute.
Document control and record keeping
Document control and record keeping – like data management – need accurate, complete, and timely records. This ensures the traceability and accountability of clinical trial activities, facilitating regulatory compliance and successful study outcomes.
Management of the IMP
Managing the Investigational Medicinal Product (IMP) according to regulations and guidelines helps to maintain the validity of the clinical trial and protect patient safety. The key principles of good management that will be assessed for your VRA accreditation include maintenance of the integrity, accountability, and traceability of the IMP, as well as how the IMP is handled, stored and dispensed. At the end of the trial, CRAs also monitor the return and destruction of unused IMP.
Contracts and financial management
Contracts and financial management are vital aspects of clinical trials, ensuring that all parties involved are adequately compensated and that the study budget is managed effectively.
Correcting or addressing discrepancies or budget issues demonstrates your impact on the successful completion of the trial but also wider business implications of running a clinical trials site. Key elements to impart during your CRA accreditation assessment are the importance of clear and fair contractual terms, timely payments, and keeping to budget.
Quality assurance and quality control
The essential activities CRAs conduct on behalf of quality assurance (QA) and quality control (QC) are regular monitoring visits, audits, data verification and inspections. The key aim is to identify and resolve quality issues to ensure the credibility and reproducibility of clinical trial results. Application of QA across a wide range of CRA activities is a strong sign of accepting responsibility for the success of the trial.