The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization?

Emily 1113

Registered
The FDA regulations (21 CFR 312.3) define theSponsorof the IND application asthe person who takes responsibility for and initiates a clinical investigation. The Sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. But it doesn't imply clearly about the number of the IND sponsor, is it allowable that IND sponsor involves more than one individual or organization?
Thanks a lot
 
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v9991

Trusted Information Resource
The FDA regulations (21 CFR 312.3) define theSponsorof the IND application asthe person who takes responsibility for and initiates a clinical investigation. The Sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. But it doesn't imply clearly about the number of the IND sponsor, is it allowable that IND sponsor involves more than one individual or organization?
Thanks a lot
i am not into ...just an inquisitve person adding to the discussion with traceable/attri butable references.

Q1.4: What considerations are important when planning a complex clinical trial as a co sponsorship? Multiple co-sponsors, that can be an individual, a company, an institution or an organisation, are possible as per the EU CTR Article 71. Thus, a conduct of complex clinical trials (e.g., platform clinical trials) may be governed by a collaborative network of co-sponsors, for example by networks of researchers or research institutions within disease-focused consortia. The governance rules and structure to ensure oversight and timely decision-making need to be considered at the planning stage by means of establishment of relevant committees (e.g., overall, and sub-protocol specific steering committees, data monitoring committees) and a communication plan (See Q7.4).
 
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