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Requirements & Obligations

It is essential to ensure the roles and responsibilities are understood by all parties involved throughout conduct of the trial. An Investigator-sponsored study requires an investigator and/or their institution fulfill the obligations and responsibilities of both the sponsor and investigator, including all applicable regulatory requirements. As a study sponsor, the investigator must maintain ownership of the study protocol and any data generated throughout the study.  The investigator is also responsible for securing all regulatory approvals and assuring the validity of the study data.  The table below illustrates some common differences between industry sponsored and investigator-sponsored responsibilities:

  Industry Sponsored Investigator-Sponsored
PROTOCOL DESIGN & AUTHORING Company owns protocol and investigators invited to contribute Investigator owns the protocol with option to submit to multiple resources for funding
RESOURCE ALLOCATION Company obtains adequate resources for study conduct in conjunction with investigator Investigator solely responsible for acquisition of resources for study conduct
DATA COLLECTION & ANALYSIS Company controls data & collection through subject consent and investigator has access to their data only The investigator controls all data and collection with subject consent and gives company right to use the data
INFORMED CONSENT FORM (ICF) Company may provide an ICF template or suggestions to investigator prior to approval from Regulatory Agency  Investigator solely responsible for authoring the ICF proir to approval from Regulatory Agency
REGULATORY OVERSIGHT Company may provide updates and submissions to Regulatory Agency on behalf of study investigator Investigator solely responsible for securing and maintaining all regulatory approvals throughout the study
DELIVERABLES Generally determined by company according to strict timelines and requirements Investigator works in tandem with company to determing the requirements
PUBLICATION The company and steering committee determine authorship Investigator determines authorship
INTELLECTUAL PROPERTY Company has the rights to all intellectual property development from the study data Intellectual property generally defined and varies depending on study protocol and terms of study agreement

It is important to note that any submission involving a device or study population that is not consistent with the current device labeling indication(s) (i.e. “off-label” use of marketed devices) will require an Investigational Device Exemption application (IDE) to the U.S. Food and Drug Administration (FDA) or local regulatory equivalent and approval by the agency prior to initiation of the study.  Please visit www.fda.gov for further information regarding this process.

Furthermore, the Sponsor-Investigator must comply with recognized ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (www.icmje.org), established by the International Committee of Medical Journal Editors (ICMJE).  TMC recommends you and your institution add your study to the FDA’s ClinicalTrials.gov database (www.clinicaltrials.gov) or similar trial registry website in your country.  Please note this may also be a prerequisite for publishing in select journals (e.g., the ICMJE).

 

For additional information about your responsibilities as a sponsor, please visit the following public websites:

Good Clinical Practice:

http://www.fda.gov/ohrms/dockets/ac/04/briefing/4028B1_08_GFI-ICH%20E6.pdf

Code of Federal Regulations 21:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

ICH Guidance Documents:

http://www.fda.gov/RegulatoryInformation/Guidances/ucm122049.htm

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