Sponsor's roles/responsibilities Flashcards
Before an investigator can begin a study, the sponsor shall obtain the following items:
Part 312
1) Form 1572
2) Investigator CV
3) Clinical protocol (standard of practice)
4) Form 3455 or 3454 (FDF)
Crucial components in Form 1572:
1) IND numbers to be conducted by investigator
2) Name and address of IRB responsible for review/approval of studies
3) Site location
4) Commitment by investigator to conduct study according to relevant regulations
What are 10 crucial responsibilities of a sponsor?
-Study design and planning
-Funding and resources
-Site selection and management (provide training)
-Monitoring and oversight
-Safety management
-Data management and analysis
-Compliance and quality assurance
-Reporting to regulatory bodies, IRB/IEC, and stakeholders.
-Participant welfare through examining ICF prior to study procedures in the context of strict ethical consideration.
-Publication and dissemination
Who submits the investigator brochure (IB) to the IRB and who keeps it up to date?
Sponsor
What the hell is the point of monitoring ?
1) Ensure rights and well-being of human subjects are protected.
2) Ensure reported data are accurate, complete, and VERIFIABLE via source docs.
3) Trial is conducted in compliance with protocol, GCP, and regulatory requirements.
True or False: According to the ICH GCP, The investigator should develop a systematic, prioritized, risk-based approach to monitoring clinical trials.
F; sponsor dictates this.
What is centralized monitoring?
Sponsor provides remote monitoring of a site with a team of trained persons (e.g., data managers, and etc).
What should a sponsor verify during an on-site visit?
-Storage times/conditions of investigational product (IP)
-Study products are delivered to appropriate subjects
-Subjects are provided with sufficient education on use/storage, and handling
-Receipt, use and return of IP is controlled and documented.
-Disposition of unused IP is acceptable.
What are 5 biggest priorities for monitors to verify in relation to CRFs?
-Data is reported accurately and consistent with source with GCP.
-Any dose/therapy modifications are documented.
-AE, concomitant meds, and etc are reported accordingly.
-Missed visits, absence of tests/exams despite its necessity per CRF.
-Withdrawals & lost to follow-up of enrolled subjects are reported and explained.
T/F: Per ICH GCP, monitoring report is OPTIONAL after each visit or trial-related commuication.
F
What is included in a monitoring report? (7)
-Visit details (Date/Site info/staff involved)
-Purpose (routine, SIV, close-out visit)
-Study progress (endpoint efficacy, enrollment targets, and etc.)
-Findings and action items (missed PD, AE, queries, and etc.
-Verification of data consistency and accuracy between CRF and source.
-Site-communications, decisions made during the visit
-Signatures and approvals
What is a monitoring plan?
A document that serves as a roadmap for monitoring activities and defines how the trial’s progress and data integrity will be managed. It protects trial integrity and ensures patient safety through a systematic method of promptly identifying possible issues.
What is an audit
systematic, independent examination of a trial to ensure compliance with regulations, protocols, and standards. It is to assess the accuracy, completeness, and reliability of the data and to verify that the trial was conducted in accordance with GCP, regulatory requirements, and the study protocol.
Who determines the proper storage temperature, condition, time and procedures for the investigational product?
Sponsor
How long will sponsor maintain records showing shipment, receipt of test articles (including names of investigators/sites)
2 years
