/
Sponsor Responsibility GCP
Save to my account
Sign up
Sponsor Responsibility GCP
Sponsor Responsibility GCP
Study
1
Question
What will you be able to do at the end of the lecture on Sponsor Responsibility II GCP?
Answer
Gain a basic understanding of the sponsors responsibilities in various aspects of the conduct of the clinical trials.
2
Question
What should the sponsor ensure regarding safety and efficacy data before planning trials?
Answer
The sponsor should ensure that sufficient safety and efficacy data from non-clinical studies and/or clinical trials are available to support human exposure by the route, at the dosages, for the duration, and in the trial population to be studied.
3
Question
When should the Investigators Brochure be updated?
Answer
The sponsor should update the Investigators Brochure as significant new information becomes available.
4
Question
What aspects should the sponsor ensure about the Investigational Products (IP)?
Answer
The sponsor should ensure that: 1. The IP is characterized as appropriate to the stage of development of the products. 2. The IP is manufactured in accordance with any applicable GMP. 3. The IP is coded and labelled in a manner that protects the blinding, if applicable.
5
Question
What should the labelling of investigational products comply with?
Answer
The labelling should comply with applicable regulatory requirements.
6
Question
What storage conditions should the sponsor determine for the IP?
Answer
The sponsor should determine the storage temperatures, protection from light, storage time, reconstitution fluids and procedures, and devices for product infusion, if any.
7
Question
What is the purpose of packaging investigational products?
Answer
The investigational products should be packaged to prevent contamination and unacceptable deterioration during transport and storage.
8
Question
What should the coding of IP in blinded trials include?
Answer
The coding should include a mechanism that permits rapid identification in case of emergency but does not permit undetectable breaks of the blinding.
9
Question
What is the sponsor responsible for regarding the supply of IP?
Answer
The sponsor is responsible for supplying the investigators institutions with the investigational products.
10
Question
When should the sponsor supply investigational products to an investigator institution?
Answer
The sponsor should not supply an investigator institution with the investigational products until the sponsor obtains all required documentation, e.g. approval/favorable opinion from IRB/IEC and regulatory authorities.
11
Question
What should written procedures regarding the handling of IP include?
Answer
Written procedures should include instructions that the investigator institution should follow for the handling and storage of investigational products for the trial and documentation thereof.
12
Question
What should the procedures regarding handling of IP address?
Answer
The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from trial participants, and return of unused investigational products to the sponsor.
13
Question
What should the sponsor ensure for the delivery, record-keeping, and disposition of IP?
Answer
The sponsor should ensure timely delivery of investigational products to the investigators, maintain records that document shipment, receipt, disposition, return, and destruction of the investigational products.
14
Question
What should the sponsor maintain a system for regarding investigational products?
Answer
The sponsor should maintain a system for retrieving investigational products and documenting this retrieval, and for the disposition of unused investigational products.
15
Question
What is the sponsor responsible for concerning the ongoing safety evaluation of investigational products?
Answer
The sponsor is responsible for the ongoing safety evaluation of the investigational products and should promptly notify all concerned investigators, institutions, the EC, and regulatory authorities of findings that could adversely affect safety.
16
Question
What should the sponsor expedite regarding adverse drug reactions (ADRs)?
Answer
The sponsor should expedite the reporting to all concerned investigators, institutions, and to the RA and/or EC, where required, of serious and unexpected ADRs.
17
Question
What key clinical trial documents is the sponsor responsible for preparing?
Answer
The sponsor is responsible for preparing all clinical trial documents, including IB, Protocol, Case report form, Informed consent document, trial participant Diary, Standard Operating Procedures, and other required written information.
18
Question
What should record access allow for in terms of trial-related activities?
Answer
Record access should allow for trial-related monitoring, audits, RA and/or EC review, and regulatory inspection.
19
Question
What should happen if non-compliance is discovered during a trial?
Answer
If non-compliance significantly affects or has the potential to affect trial participant protection or the reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.
20
Question
What should the sponsor do if an investigator's institution is persistently non-compliant?
Answer
The sponsor should terminate the investigator's institution's participation in the trial and promptly notify the EC and RA.
21
Question
What should the sponsor do if a trial is prematurely terminated or suspended?
Answer
The sponsor should promptly inform the investigators institutions and the RA and EC of the termination or suspension and provide the reasons.
22
Question
What responsibilities does the sponsor have in multicenter trials?
Answer
The sponsor should ensure that all investigators conduct the trial in strict compliance with the protocol and that the CRFs capture the required data at all multicenter trial sites.
23
Question
What should communication between investigators in multicenter trials facilitate?
Answer
Communication between investigators should facilitate instructions on following the protocol, compliance with a uniform set of standards, and completion of the CRFs.
24
Question
What are the two major responsibilities that will be discussed separately?
Answer
Monitoring and Audit.