Investigators brochure - Study guides, Class notes & Summaries

CCRP SoCRA Exam Latest Update Rated A 21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel 21 CFR Part 56 Subpa...

ACRP CP FINAL EXAM LATEST 2024/2025 REAL EXAM | QUESTIONS AND CORRECT ANSWERS LATEST What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWER- Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - ANSWER- Validation, accuracy, reliability, completeness Part of a sponsor's responsibility pertaining to elect...

ICH GCP for CCRC Exam Prep|543 Questions and Answers 2023 Graded A+. Adverse Drug Reaction (ADR) Correct Answer: All noxious and unintended responses to a medicinal product related to any dose E6(R1) 1 Correct Answer: Glossary of terms Adverse Event (AE) Correct Answer: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment--any unfavorable and uninten...

CITI Training 134 QUESTIONS Graded A+ Solved 2023 What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant...

ACRP-CP Certification Exam QUESTIONS AND CORRECT ANSWERS | ALREADY PASSED What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWER : Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for - ANSWER : Validation Accuracy Reliability Completeness Part of a sponsor's responsibility pertaining to el...

ACRP-CP Certification Exam QUESTIONS AND CORRECT ANSWERS | ALREADY PASSED What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWER : Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for - ANSWER : Validation Accuracy Reliability Completeness Part of a sponsor's responsibility pertaining to el...

When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential) How man...

ACRP CCRC Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the investigators' meeting. Following the meeting, the entry criteria are altered to facilitate the recruitment and retention of eligible subject. Prior to trial start-up, the regulatory binder must include: 1.An IRB/IEC letter of approval for the amended protocol 2.An IRB/IEC ...

SOCRA CERTIFICATION & PRACTICE ACTUAL EXAMS COMBINED 400+ QUESTIONS WITH EXPERT CORRECT DETAILED SOLUTIONS WITH RATIONALES | ALREADY PASSED | Grade A+ How long are IRB records required to be maintained after completion of a study? - ANSWER 3 years (and accessible!). FDA can shut it down if IRBs are not keeping records appropriately Are there a lot of required documentations and records by the IRB? - ANSWER Yes. Lots of written procedures, must keep copies of meeting minutes, c...

SOCRA Questions and Answers Already Passed When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependen...