Clinical trials endure a large amount of resources and costs. Thus, for the efficient functioning of a clinical trial, it is important to have a sponsor who would take the medico-legal responsibility of funding and managing the clinical trial. The sponsor is an individual, company or an institution which finances the conduct of a clinical trial. On the other hand there could also be a sponsor-investigator. This is a study investigator who takes responsibility for clinical study conduct, overseeing of the clinical trial and also taking the responsibility as a clinical study sponsor. It is important that a sponsor-investigator complies with the applicable regulatory requirements pertaining to both the investigator and the sponsor. The sponsors generally hire a contract research organization to mediate between the site and the sponsor to conduct the trial effectively.
There are many functions and responsibilities which a sponsor must adhere to:
- Selection of investigators for the study: It is an important task to select the right principal investigators. The investigators who are selected must be competent in knowledge, qualifications, experience and have the passion to comply with clinical trial ethics and conduct the study with passion.
- Providing investigators with the needed information to conduct the clinical trial: In order to conduct any clinical trial, it is important that it is performed according to the clinical trial protocol. The sponsor has a responsibility to ensure that the sites receive the latest version of the protocol and investigator brochure. The study staff must be trained on the latest protocol too. The clinical trial sites are generally trained by the contract research organization on behalf of the sponsor.
- Clinical Study Monitoring: This is the act of overseeing the progress of the clinical study and monitoring is an important element in ensuring GCP. It is very important that a study is conducted, recorded as well as reported in compliance to standard operating procedures and the protocol. Thus, a sponsor takes responsibility to ensure that the sites are well monitored. This ensures that sites meet the required standards and data quality, while the safety of subjects are maintained.
- Ensure that ethics reviews and approvals are obtained: Prior to initiating a clinical trial, it is important to have the clinical trial protocol submitted to the ethics committee for their independent review and approval. This is something which the study sponsor should initiate.
- Clinical trial application (CTA) submission: The CTA must be submitted to the national regulatory authority and an authorization must be obtained on clinical trial conduct in a specific country where the clinical trial is being performed. The key documents which are submitted includes, information on the investigational product, manufacturer/importer authorizations, as well as drug labels and qualified person declaration. In addition, if there are amendments these should be submitted too to the regulatory authorities.
- Prompt communication of serious adverse events and safety issues to the ethics and regulatory agencies: Clinical trials need to protect patient safety and therefore prompt reporting to the ethics and regulatory agencies are necessary. Further, new product information of the clinical study needs to be submitted by the sponsor too as soon as it is available.
- Ensuring compliance and GCP: The sponsor must ensure that the clinical trial is done in accordance to GCP guidelines and that regulatory requirements of the particular country where it is conducted in is met.