Socra certification class - Study guides, Class notes & Summaries

SOCRA Practice 1 questions and answers latest 2023 True or False The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) is sponsored by a licensed medical practitioner who becomes a sponsored investigator. 21 CRF 312.35 True or False Investigators are responsible for periodically requesting updates regarding new information gleaned by a ...

SOCRA- 2023 100% accurate answers Belmont Report was created as part of? The national Research Act of 1974. Who was the Belmont Report formulated by? The National Commission for the protection of human subjects in biomedical and behavioral research. What year was the publication of the FDA regulations made? 1980 *1981 for the HHS and revised FDA Regulations. What year was GCP and HIPAA created? 1996 What is the National Research Act? A set of regulations for the...

The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - Answer - European Union, Japan and United States What organizations are represented in the ICH Steering Committee? - Answer - Australia, Canada, the Nordic countries and the World Health Organization (WHO), European Union, Japan, and the United States What ethical standards are the ICH Documents based on? - Answer - Declaration of Helsinki What is the ...

2024 SOCRA Certification Assessment Test Exam With Elaborate Answers 1] The IRB will determine if a study is morally justified and demonstrates what key 4 items? - ANSWER 1. Adequate design 2. a favorable risk/benefit ratio 3. equitable selection of subjects 4. informed consent by subjects 2] What all does the 1572 contain? - ANSWER 1. Name/Address of investigator 2. Name and protocol # 3. Name and address of every facility where clinical investigations will take place 4. Na...

SOCRA Certification Exam Questions and Answers The IRB will determine if a study is morally justified and demonstrates what key 4 items? - Answer-1. Adequate design 2. a favorable risk/benefit ratio 3. equitable selection of subjects 4. informed consent by subjects What all does the 1572 contain? - Answer-1. Name/Address of investigator 2. Name and protocol # 3. Name and address of every facility where clinical investigations will take place 4. Name/Address of any clinical lab 5. Name...

Socra exam-Forms and Device info 100% SOLVED Form 3454-Financial Interest Certification - ANSWhat form is used for the certification of financial interest and arrangements of clinical investigators? Form 482-Notice of inspection - ANSWhat form is used for the reporting of an upcoming inspection or audit? Form 483-Inspectional Observations - ANSWhat form is used for the reporting of audit/inspection findings? Form 3500-Voluntary AE and product problem report - ANSWhat form is used for th...

SoCRA Certification Exam Questions with complete answers Biometrics Closed System Digital Signature Electronic Record Electronic Signature Open system Clinical Investigation Investigator Sponsor Sponsor-Investigator Handwritten Signature Act Human Subject Institution Institutional Review Board (IRB) Test Article Minimal Risk Legally Authorized Representative Family Member Assent Children Parent Ward Permission Guardian Emergency Use IRB Approval Contrac...

The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - Answer- European Union, Japan and United States What organizations are represented in the ICH Steering Committee? - Answer- Australia, Canada, the Nordic countries and the World Health Organization (WHO), European Union, Japan, and the United States What ethical standards are the ICH Documents based on? - Answer- Declaration of Helsinki What is the sta...