Brainscape
Find Flashcards
Make Flashcards
Why It Works
More
Educators
Businesses
Tutors & resellers
Content partnerships
Academy
About
Educators
Teachers & professors
Content partnerships
Tutors & resellers
Businesses
Employee training
Content partnerships
Tutors & resellers
Academy
About
Log In
Brainscape's Knowledge Genome
TM
Entrance Exams
Professional Certifications
Foreign Languages
Medical & Nursing
Science
English
Humanities & Social Studies
Mathematics
Law
Vocations
Health & Fitness
Business & Finance
Technology & Engineering
Food & Beverage
Fine Arts
Random Knowledge
Top Flashcards (Certified)
All Flashcards
Clinical Research Regulations
> ICH E2A > Flashcards
ICH E2A Flashcards
Study These Flashcards
Study These Flashcards
Clinical Research Regulations
(31 decks)
45 CFR 46
The Nuremberg Code - C
The Belmont Report - C
The Declaration of Helsinki - C
21 CFR 11
21 CFR 50
21 CFR 56
21 CFR 312
21 CFR 812
ICH GCP Rev2
ICH GCP Rev3 (not for exam)
ICH E2A
FDA forms
Coordinate the development of initial research study protocol
Create or obtain research study documents
Obtain research study approval from necessary stakeholders
Obtain research study product, related materials, equipment, tools and aids
Select research study sites
Train research study staff members
Evaluate research study's compliance with relevant local, state and provincial laws
Execute Research Strategy
Assure regulatory compliance
Manage research study product
Identify, document & report research study anomalies
Manage subjects Recruit subjects
Maintain the research study
Communicate with research study stakeholders
Perform/participate in a research study audit
Perform/participate in a research study closeout visit
Develop & submit research study closure reports
Archive/retrieve research study records
