The content of the CRA/CRC training
program for follows the examination questionnaire of the Association of Clinical Research Professionals and includes the following topics:
1) Overview of
the pharmaceutical industry
2) History of the clinical trials regulations
3) Phases of
clinical trials, Glossary of terms
4) Ethical
principles in CR, Medical terminology
5) Role and tasks of the Sponsor, PI, CRC & CRA
6) Overview of Drug Regulatory Process, 21 CFR
7) Canadian Clinical Trials Regulations, ICH GCP
8) Institutional
Review Board, IRB/IEC/REB
9) Informed Consent Process, ICD design
10) Safety
monitoring and AE/SAE reporting
11) Study
Preparation and Clinical Trial Design
12) Fundamentals of clinical trials conduct
13) Design of Clinical Trial Protocols
14) Design of Case Report Forms (CRF)
15) Site management,
Recruitment & Retention
16) Site
Evaluation and Site Selection Visit
17) Investigator
Meeting & Site Initiation Visit
18) Monitoring
Plan and Site Monitoring Visit
19) Study
Termination, Site Close-Out Visit
20) Preventing
Errors, Fraud and Misconduct
21) Clinical
Trial Data Management
22) HIPAA
Compliance Requirements
23) Data Safety
Monitoring Board
24) EDC & Clinical
Trial Management Systems
25) Sponsor's Audits
and FDA Inspections
26) Essential
documents in clinical trials
27) Medical
devices, 21 CFR part 820
28) Pre-market
notification, FDA 510(k) PMN
29) Investigational Device Exemption, IDE
30) Medical
Devices Pre-market Approval, PMA
31) Time management and Monitoring fficiency
32) CV
adaptation, Job descriptions, CR Interviews
In parallel 3 additional topics are discussed:
1. Job Search Methods for the Clinical Research industry
2. Networking 2.0: How to access the Hidden Job Market
3. Personal Branding: The Art of Self-marketing & Positioning
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