What are general responsibilities of the sponsor in clinical trials according to ICH GCP?
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Oxford University Press makes no representation, express or implied, that the drug dosages in this book are correct. Readers must therefore always … More Oxford University Press makes no representation, express or implied, that the drug dosages in this book are correct. Readers must therefore always check the product information and clinical procedures with the most up to date published product information and data sheets provided by the manufacturers and the most recent codes of conduct and safety regulations. The authors and the publishers do not accept responsibility or legal liability for any errors in the text or for the misuse or misapplication of material in this work. Except where otherwise stated, drug dosages and recommendations are for the non-pregnant adult who is not breastfeeding. You do not currently have access to this chapter. 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. 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 the roles and responsibilities of sponsor in clinical trials?The trial Sponsor is responsible for the initiation, management and financing (or arranging the financing) of the trial and carries the medico-legal responsibility associated with its conduct.
Which of the following is the responsibility of the sponsor?Generally, a sponsor is responsible for: Selecting the investigator(s) Providing investigator(s) with the necessary information to conduct the clinical trial. Ensuring proper monitoring of the clinical study.
What should be expected from the sponsor of a clinical trial?Some of the responsibilities of a sponsor may include: Designing the study to address key research or medical questions. Finding and hiring qualified study investigators. Ensuring investigators are briefed on all data pertinent to the clinical study.
Which responsibilities are covered under ICH GCP e6?The addendum adds specific requirements that the SOPs must include system setup, installation, use, validation and functionality testing, data backup, recovery, and training for users. The addendum also clearly puts the responsibility for reliable data on the sponsor, requiring in section 5.5.
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