Log in
Register|
raghavendra_s ★ 2010-04-29 13:29 (5489 d 12:38 ago) Posting: # 5267 Views: 6,897 |
|
|
Dear Madam/Sir, A sponsor contracted a Phase 1 trial to the CRO, CRO conducted the trial and followed their own SOP's in all the aspects including the TMF also, after completion of the trial all the documents sent to the sponsor, here my question is according to whose SOP these documents should maintain. What happens, if any regulatory body audits the CRO for this study. Thanks and regards, |
|
Dr_Dan ★★ Germany, 2010-04-29 14:14 (5489 d 11:54 ago) @ raghavendra_s Posting: # 5269 Views: 5,669 |
|
|
Dear raghavendra You said that after completion of the trial all the documents were sent to the sponsor. I think you sent copies but kept the originals, right? According to CMP/ICH/135/95 you have to keep the essential documents at your side and for this you should follow your SOPs. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
|
Ohlbe ★★★ France, 2010-04-29 14:14 (5489 d 11:54 ago) @ raghavendra_s Posting: # 5270 Views: 5,690 |
|
|
Dear Raghavendra, ❝ after completion of the trial all the documents sent to the sponsor Do you mean to say that nothing was retained by the CRO ? Regards Ohlbe — Regards Ohlbe |
|
raghu ★ India, 2010-04-29 20:23 (5489 d 05:45 ago) @ raghavendra_s Posting: # 5271 Views: 5,618 |
|
|
Dear Raghavendra Always, the source data generated@ clinical trail site/Lab/Pharmacy should be stored at clinical trail site/Lab site/pharmacy, follow as per GCP. Regards Raghavender |
|
Debbie ★ India, 2010-05-30 20:37 (5458 d 05:31 ago) @ raghu Posting: # 5401 Views: 5,481 |
|
|
Hi, is it compulsory that the original documents shall be retained by the trail sit (CRO)? If, the sponsor has asked to provide the original documents and asked the CRO to retain the copy of the documents. as per Dr. Dan's comments in the above post, as per CMP/ICH/135/95, i could not find any statement saying that the trail site(CRO) must retain the original documents. instead, as per the ICH-E6 GCP guidance (page no 50), the original copy of the CRF shall be maintained by the sponsor and a copy shall be retained with the investigator/institution. please comment whetther the trail related original documents should be kept with trail site (CRO) or the sponsor. Regards, |
|
Dr_Dan ★★ Germany, 2010-06-02 13:33 (5455 d 12:34 ago) @ Debbie Posting: # 5409 Views: 5,392 |
|
|
Hi Debbie you are right, there is no recommendation whether the trail related original documents should be kept with trail site (CRO) or the sponsor. This should be clarified in an agreement. Usually the original essential documents are kept with the trial site since also some documents which should not be forwarded to the sponsor (e.g. Subject Identification Log) are kept there together with internal (not essential but original) documents (staff, timetables, certificates) which might become important during an inspection. I know that some sponsor like to have the original documentation but I see no need for that. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz