Based on gcp, the sponsor is responsible primarily for study design and management as well as
In the conduct of a clinical trial, a sponsor is an individual, institution, company or organization (for example, a contract research organization) that takes the responsibility to initiate, manage or finance the clinical trial,1 but does not actually conduct the investigation. Show
A sponsor-investigator, on the other hand, takes on the responsibility as a clinical study sponsor and also conducts or oversees the clinical trial. Thus, a sponsor-investigator must comply with the applicable regulatory requirements that pertain to both the sponsor and the investigator.2,3 Clinical trials: Study sponsor responsibilitiesThe specific regional requirements for a clinical study sponsor can vary. Generally, a sponsor is responsible for:3,4
Clinical trials: Study investigator responsibilitiesIn a clinical trial, the responsibilities of an investigator generally include:
Sponsor-investigators: Additional considerationsSponsor-investigators also generally need to manage the following1:
Sponsor-investigators: Getting started with a clinical trial applicationWhile the completion of a clinical trial application involves many tasks and may seem daunting, there are many resources to help. The following approach can assist you:
Disclaimer The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional. Published: October 17, 2012 References
What are general responsibilities of the sponsor in clinical trials according to ICH GCP?5.1. 1 The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).
What are the sponsor responsibilities?Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols ...
Who is mainly responsible for making sure that clinical trial protocol is in line with GCP guidelines?1 A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions. 4.3.
What are the 3 main GCP principles?Risk minimization. Subject's rights, safety, and well-being. Adequate drug information.
|