Lesson:ICH GCP Section5 Sponsor/CRO Responsibilities Flashcards
What are an sponsor’s responsibilities?
-select Investigator
-monitor safety
-maintain required records and report
-Ensure trial is conducted in accordance with protocol.
Sponsor responsibilities ?
-Clinical Trial Authorization and Ethics Committee Opinion ( approval,amendments and end of trial)
-GCP & Conduct ( arrangement to adhere and ensure compliance with GCP and regulations)
-Pharmacovigilance ( keep record of AEs, expedite and annual reporting of safety issues to REC and CA and other investigators)
** sponsor may delegate some or all these responsibilities BUT retain overall responsibility for the trial and must maintain oversight to ensure trials are compliant.
Type of sponsor ?
-Commercial Institution
-Non commercial institution
-charity organization
CRO and sponsor !
A sponsor may transfer any or all of the sponsor’s trial related duties and function to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.
CRO should implement QC and QA
Sponsor and medical expertise.
The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions.
When using electronic trial data handling and /or remote electronic trial data system the sponsor should?
Ensure and document that the electronic data processing system conform to the sponsor’s established requirements for completeness accuracy, reliability and consistent intended performance (I.e validation )
Sponsor : data management SOP checklist
SOP shoul cover:
-System setup, installation and use
-system is designed to permit data changes (no deletion of entered data —> audit trail)
-Maintain a secure system
-safeguards the blinding
-list of people who can make data changes
-ensure the integrity of the data
Sponsor code and essential documents
Sponsor should use an unambiguous identification code covering all the data reported for each subject.
Sponsor should retain all of sponsor-specific essential documents
Essential Document.
Sponsor essential document should be retained until at least ____after the last approval of a marketing application in an ICH region.
1-2 years
Sponsor should provide insurance or should indemnify the investigator/the institution against claims arising from the trial except for claims arises from
Malpractice
Or Negligence
Before initiating trial, the sponsor and investigators should submit required applications to appropriate authorities for
Review
Acceptance
Permission
Any submission should be dated and include protocol identifier
During planning, ensure that safety and efficiency data are available to support human exposure
By the route
At the dosage
For the duration
In the trial population
Update Investigator’s Brochure as new information becomes available
Manufacturing, packaging, labeling and coding IP
-Package to prevent contamination and unacceptable deterioration.
-Blinded trial should include a mechanism for rapid product identification in case a medical emergency
-Should not permit undetectable breaks
-Results of studies on significant formulation changes should be assessed before new clinical trials
Maintain record of IP like
Shipment receipt
Disposition
Return
Destruction
Safety information
Sponsor is responsible for ongoing safety evaluation of the IP and should notify all investigators/institution and regulatory authorities of finding that could
Adversely effect safety of subjects
Impact conduct of trial
Alter IRB approval
