SPONSOR AND INVESTIGATOR- RESPONSIBILITIES IN CLINICAL TRIALS

 

In Clinical Trial studies, a team of members namely the investigators, the ethics committee, sponsors, regulators, data safety monitoring board, subject experts & independent experts works together intending to evaluate certain behavioral, surgical, and medical interventions. Let’s find out the responsibilities of the primary members.  

Sponsors and their Responsibilities

A Sponsor is an individual, institute, company, or organization that initiates, manages, and/or finances the Clinical studies. Government funding agencies, Private foundations, Commercial companies like Pharmaceutical or Medical Devices, and Individuals are considered sponsors. The sponsor team members are Monitors/ CRA, CRO, Project Managers, Biostatisticians, Data Managers, and Medical Writers. The responsibilities of sponsors are listed in below Table 1.

	Quality Assurance & Quality Control (QA & QC) The sponsor ensures that the trial is performed, documented, recorded & reported as per the protocol, GCP & applicable regulatory requirements. Helps easy access to data by sponsor & investigator.
	Medical experts Sponsors need to hire qualified persons who can easily conduct & solve the queries of the clinical trials.
	Trial Design The sponsor must utilize experts and design the clinical trial studies as per the protocol, GCP & regulatory guidelines.
	Managing & Handling trial data Sponsor must establish IDMC to maintain SOPs & retain essential documents for a period of at least 2 years.
	Investigator selection Sponsors tie an agreement with investigators who help them to conduct CT as per Protocols.
	Compensation & financing Sponsors design the cost of compensation to be paid to subjects in compliance with regulatory bodies. He also helps the investigators to finance the conduct & not malpractices. A financial agreement is signed between sponsors & investigators.
	Notification/Submission to Regulatory bodies   Application of the study is submitted to Regulatory bodies for granting persons to conduct trials.
	Drug product Information Adequate nonclinical study information about the drug product is a must to support human exposure. Also include manufacturing & packaging details of the drug product.
	Safety Information The sponsor must evaluate the trials on daily basis to protect subjects from adverse effects & notify other members for immediate safety measurements.
	Monitoring, Auditing & Generating CSR The sponsor must monitor & audit the study data as per SOPs, Protocols & Guidelines to generate a Clinical study report.

Investigators and their Responsibilities

An Investigator is a person who will conduct a clinical study at the trial site. He is also referred to as the Principal Investigator (PI) if the trial studies are performed by a team of experts at different study sites. They aim to perform trials, record the findings of the trials and report the data w.r.t regulatory standards provided by regulatory bodies. The responsibilities of investigators are listed below in Table 2.

Table 2. Investigator’s Responsibilities in Clinical trials

	Qualifications & agreements An investigator must be a qualified person & have hands-on experience to conduct clinical trials and agree to comply with regulatory requirements.
	Adequate Resources The investigator needs to identify staff & site facilities to generate authentic data.
	Patient care An investigator is responsible to protect the patient medical records & provide adequate medical care.
	Communication Investigators need to get approval from IRB/IEC before conducting a trial & must notify about any SAEs/AEs during treatment.
	Compliance with protocol  Investigator ensures that no error occurs within the protocol without prior notification to sponsors and IRB/IEC.
	Investigational Product (IP)  IP should be maintained, used &/or returned, & stored as per protocols only.
	Informed Consent (IC)  IC is provided to subjects in a language that is understandable to them by the investigator where ample questions are to be answered.
	Record & Report   An investigator must ensure that the data recorded is accurate, complete, legible & within reported timelines which are summaries briefly in reports.
	Safety reporting An investigator must notify sponsors immediately in case of SAEs or any critical condition affecting the patient.
	Final reports Provide a summary of the trial outcome to an institution and IRB/IEC.

Conclusion

The clinical trials are conducted by different professionals who are a team with several responsibilities. Each work goes hand in hand. The main purpose is to maintain patient rights, to safeguard them, and the well-being of the participant concerning GCP and regulatory requirements. Thus, sponsors & investigators are key persons while conducting clinical trials.

 

References

1.  International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use. ICH Harmonized Tripartite guideline. Guideline for the good clinical practice: E6(R1); 1996; June 10.
2.  Responsibilities of sponsors. Selecting investigators and monitors. 21 CFR 812.43. US Food and Drug Administration. Updated September 19, 2019. Accessed July 25, 2019.
3. Investigator responsibilities – protecting the rights, safety, and welfare of study subjects. Guidance for industry. US Food and Drug Administration. Published October 2009. Updated April 12, 2019. Accessed October 12, 2019. 

 

Shraddha Khobragade

Master of Pharmacy

CSROL_INT_ONL_WKD_188/2022