Dear Colleagues, Is it possible with Clinical Trial Applications in the EU for the Sponsor to submit the IMPD and for the CTA submission to progress via a CRO? thereby keeping the IMPD confidential.
If you have a clinical trial already approved with the same IMPD in the country, you can ask the CRO to cross-refer to the IMPD already approved in their CTA.
Hope this helped!
if you did not submit a previous CTA with the same IMPD, the other option would be to contact the Regulatory Authority (RA) and inform them that the IMPD is submitted separatly from the CTA. The CRO would need to cross refer in the CTA to the IMPD submission done directly by the sponsor.
I would discuss this strategy with the CRO and agree on who will contact the RA to validate this submission strategy country by country.
On a side note, the CRO is supposed to manage any sponsor document in a confidential way, including the IMPD. This two wave CTA submission is not optimal in terms of process and risk management.
Thank you so much - I really appreciate the feedback.
Thank you for the feedback _ I really appreciate it
We discussed this question in our recent CMC SPIN Steering group meeting.
Although none of us has direct experience of this situation, I agree with other posts that the best approach would be to discuss the situation with each individual RA concerned with the proposal for cross reference between the individual submissions. I do feel however that this could become complicated in the case of questions and responses eg each RA would need to issue separate list of questions to different contacts.
Worth checking but I would assume that relevant confidentiality agreements are in place between your company and the CRO and in which case, sharing of these files should not be a major concern.
I agree with the responses above. You have probably thought of this, but it is important to remember that some CMC information must be added to the application form. You should probably also consider ensuring there is a system in place for the CRO to notify the RA of an update to the IMPD that they are cross referring to.
Is there an ASMF, this could be used for cross referral while the DP section of the IMPD is provided to the CRO - the exception being that ASMFs cannot be used for biological products.