What is a Clinical Research Associate (CRA)
Clinical trials ultimately serve to provide valuable evidence-based research on emerging medical interventions. Clinical research associates (CRAs) play a vital role in the trial sponsor’s ability to conduct proper quality control of the data collected from each clinical research site.
CRAs are responsible for providing their assigned sites with oversight and guidance, monitoring patient safety, reviewing source data, and generally acting as a liaison on behalf of the sponsor. CRAs can be involved in any phase of a clinical trial, from start-up to close-out. For example, some CRAs also evaluate prospective research sites before a study begins to determine the capabilities of the facility and staff. Overall, the CRA is a key player in helping maintain the integrity of a clinical trial by monitoring a site’s practices.
COURSE CURRICULUM
- Drug Discovery and Clinical Research
- ICH GCP (Good Clinical Practice) and Schedule- Y
- 21 CFR Part 11 _ Electronic Records, Electronic Signatures
- Standard operating procedures (SOP’s)
- Protocol and Informed Consent process
- Clinical Trial Application (CTA)
- Overview of the Pharmaceutical industry
- Pre-Clinical Research Pre-Clinical Studies Of Drug / Product Candidates
- Investigational New Drug Application (I.N.D.) And New Drug Application (N.D.A)
- Phases Of Clinical Trials and BA/BE studies
- Belmont Report
- Declaration of Helsinki
- Institutional Review Board/Independent Ethics Committee (IRB/IEC)
- Good Clinical Practice & International Conference on Harmonization
- Medical Device Trials: GCP | Applications and Submissions
- Schedule – Y
- Confidential disclosure agreement (CDA)
- Form FDA 1572
- Study startup
- Informed Consent documents (ICD)
- Clinical Trial Protocol and Protocol Amendment (S)
- Clinical Trial Investigator’s Brochure
- Types of monitoring in clinical trials (On-site monitoring / Remote monitoring / Centralized monitoring / Risk-based monitoring (RBM)
- ALCOA+ and Data Integrity in Clinical Trials
- Medical Dictionary for Regulatory Activities (MedDRA)
- Safety Pharmacology Studies For Human Pharmaceuticals
- Trial master file (TMF) or Electronic trial master file (eTMF)
- Case report Form (CRF) or Electronic case report form (eCRF)
- Source Data Verification (SDV) and Source Data Review (SDR)
- Recruitment of Volunteers/Patients for Clinical Trials
- Recruitment, Retention and Compliance
- Investigation Medical Product (IMP) management
- Site Selection Visit (SSV)
- Site Initiation visit (SIV), Follow up letter and final report preparation
- Interim Monitoring visit (IMV) , Follow up letter and final report preparation
- Site Closeout visit (SCV), Follow up letter and final report preparation
- Essential Documents for the Conduct of a Clinical Trial
- AE/SAE/ADR in Clinical Trials
- Site preparation for Audit/Regulatory Inspection
- Computerized Systems Used in Clinical Trials
- Safety in Clinical Trials
- General Principles of Pharmacology
- Principles of Pharmacodynamics and Pharmacokinetic (PK/PD)
OTHERS
- Daily Tasks
- Certification Guidelines
- Sample Questions
- CV/Resume Preparation
- Mock Interviews
- Group Discussions
- Personality Development