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 responsibilities
The specific regional requirements for a clinical study sponsor can vary. Generally, a sponsor is responsible for:3,4
- Selecting the investigator(s)
- Providing investigator(s) with the necessary information to conduct the clinical trial
- Ensuring proper monitoring of the clinical study
- Ensuring all the necessary ethic review(s) and approval(s) are obtained
- Preparing and submitting clinical trial application(s) and amendment(s) to the appropriate regulatory agencies
- Ensuring that any reviewing ethics board and regulatory agencies are promptly informed of any significant new information (for example, important findings that affect product safety) in a clinical study
- Ensuring compliance with labelling, reporting and record-keeping requirements
- Refraining from engaging in promotional activities and other prohibited activities such as commercializing an investigational medical device
- Ensuring that the clinical study is conducted in accordance with Good Clinical Practice (GCP)
Clinical trials: Study investigator responsibilities
In a clinical trial, the responsibilities of an investigator generally include:
- Protecting the rights, safety and welfare of subjects in the clinical study
- Ensuring that informed consent is properly obtained from clinical trial subjects
- Conducting the clinical study (that is, directly overseeing the administration of the test products to the subject). In situations where there is a team of researchers, the investigator will act as the team leader
- Ensuring that the clinical trial is conducted in accordance with the signed agreement and the investigational plan
- Controlling the products under investigation (for example, supervising medical-device use and disposal)
- Ensuring proper record-keeping and reporting requirements are met (for example, mandatory safety reporting)3,4
Sponsor-investigators: Additional considerations
Sponsor-investigators also generally need to manage the following1:
- Securing funding for the clinical trial
- Applying for the appropriate insurance
- Generating the appropriate clinical trial documentation (for example, informed consent, protocols) and submissions (for example, ethics and/or regulatory submissions)
- Ensuring adequate resources are available for the duration of the trial (for example, experienced staff, investigational and control products, clinical and medical supplies, an analytical laboratory)
- Creating appropriate written procedures (for example, standard operating procedures related to GCP)
- Meeting all the applicable regulatory requirements such as obtaining and maintaining necessary approvals from the relevant ethics review boards and regulatory agencies
Sponsor-investigators: Getting started with a clinical trial application
While 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:
- Research the regulatory requirements pertaining to the applicable submissions. Make good use of regulatory agency websites and professional organizations as well as related publications, seminars and training.
- Contact the relevant regulatory agency via formal or informal means. Formal means may take the form of a request for a pre-submission meeting with the agency. Informal means may include contacting them with general questions.
- Prepare and submit the application based on the format and content relevant to the specific submission. Make sure that any comments or feedback received at the pre-submission meeting are incorporated in the submission dossier.
- After a submission is approved, ensure that all the post-approval requirements are fulfilled, such as any required safety reporting, annual reporting and amendment submissions relating to significant changes to the products or study plan.
- Make certain that you fulfill your responsibilities as a sponsor as well as an investigator according to applicable regulatory requirements.
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
- International Conference on Harmonisation. (1996, June). E6(R1): Good clinical practice. Retrieved September 25, 2012, from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf.
- European Community. (2001, April 4). Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities. Retrieved July 13, 2012, from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF.
- Kracov, D.A. & Dwyer, L.M. (2006). Regulatory requirements for clinical studies of medical devices and diagnostics. In Becker, K.M., Whyte, J.J. (Eds.) Clinical evaluation of medical devices. Principles and case studies. (2nd ed.). Totowa: Humana Press.
- United States Code. (2012, April 1). Title 21, Part 812, Investigational device exemption. Retrieved August 17, 2012, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812&showFR=1.