Preet
☆    

2009-03-19 09:22
(5489 d 00:12 ago)

Posting: # 3378
Views: 6,719
 

 Source Document: certified copies [GxP / QC / QA]

Dear All,

Please guide me on the above issue. Is it necessary to take signatures on the photocopy of source document for documentation purpose? (as we require to share few forms (from CRF)/documents with another department of CRO).

e.g.
1. We are sharing sampling time point deviation form with Biostatistician. In clinical department we are maintaining original copy and photocopy will be shared by statistical department. As per our current practice this photocopy is not certified (attested) by clinical department.

According to ICH GCP E6 guidelines. section 1 Glossary;
1.51 Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

Now my question is, Do we need to take signatures on the photocopy of Sampling time point deviations intended for stat documentation process?

Warm Regards,
Preet
Ohlbe
★★★

France,
2009-03-19 14:43
(5488 d 18:52 ago)

@ Preet
Posting: # 3381
Views: 5,663
 

 Source Document: certified copies

Dear Preet,

As Helmut often says: there can only be one...

I would consider the copy you make for your stats department as a working copy, not as a source document. I wouldn't be shocked if the copies were destroyed after use (if no note was taken on them at the stats department, which would then become source data), and only the original was kept in the study documentation. I wouldn't be shocked either if the stats department was provided with the original CRF pages, and returned them for archiving after use. This would also avoid possible problems with poorly legible copies. That's even why the ICH GCP guideline recommends that the original CRF be sent to the sponsor, and only a copy be kept by the investigator: in Phase II-III trials, data management is done by the sponsor, and it's easier to do it with the original CRF.

You don't need to have separate archives at each department of the CRO for the same study. It is much simpler to keep all essential documents of the study (as defined in ICH GCP, §8) centrally. There is no need then to have multiple copies of the same document.

Regards
Ohlbe
Preet
☆    

2009-03-20 07:41
(5488 d 01:54 ago)

@ Ohlbe
Posting: # 3382
Views: 5,653
 

 Source Document: certified copies

Dear Ohlbe,

First of all thanks a lot for your kind response.

My query and your response is with respect to in-house (CRO) documentation.

Now, if we require a particular document copy to be filed in CRO and we are getting courier copy or fax copy form outstation/other site. (Note: Original copy needed at other site).

In this case what is your opinion. is it required to take dated signature on the copy? if yes, how to take signature on fax copy? (here for CRO we will be treating this copy as a source document! isn't it).

Thanks & Regards,
Preet
Ohlbe
★★★

France,
2009-03-20 11:48
(5487 d 21:46 ago)

@ Preet
Posting: # 3383
Views: 5,605
 

 Source Document: certified copies

Dear Preet,

❝ we are getting courier copy or fax copy form outstation/other site❝


❝ (here for CRO wewill be treating this copy as a source document! isn't it).


Dear Preet,

The situation is a bit more complex here. I would still consider the original document to be the source document, to be archived by the other CRO. I would not require a signature from the other CRO on the copy you get or on the fax. However this time I would recommend you to archive your copy in your study documentation.

The easiest would be to get a list of sampling time deviations (or whatever information you need) from the first CRO, not just copies of the CRF pages ;-)

Regards
Ohlbe
Preet
☆    

2009-03-20 13:33
(5487 d 20:01 ago)

@ Ohlbe
Posting: # 3384
Views: 5,618
 

 Source Document: certified copies

Dear Ohlbe

❝ The situation is a bit more complex here. I would still consider the

❝ original document to be the source document, to be archived by the other

❝ CRO. I would not require a signature from the other CRO on the copy you

❝ get or on the fax. However this time I would recommend you to archive your

❝ copy in your study documentation.


❝ However this time I would recommend you to archive your

❝ copy in your study documentation.


We are following this practice. I am very much clear now.

One last doubt:
In CRO, we are using one form for Plasma Sample transfer (from clinical dept to Bioanalytical dept) and this form is filled by both clinical dept and BA dept. Last form entry will be done by bioanalytical dept personal. In this case where to file this form as source document; in Clincal dept or in Bioanalytical dept?

Currently, we are filing this original form in Clinical dept and photocopy (without sign & date by BA dept on photocopy) in BA dept. is this the correct practice?

Once again, are dated signatures needed on the photocopy?

Or shall we file these documents centrally as advised by you in first response without filing the photocopies in BA dept.

Kind Regards,
Preet
Ohlbe
★★★

France,
2009-03-20 16:43
(5487 d 16:51 ago)

@ Preet
Posting: # 3385
Views: 5,596
 

 Source Document: certified copies

Dear Preet,

❝ In this case where to file this form as source document; in Clincal dept

❝ or in Bioanalytical dept?


❝ Or shall we file these documents centrally as advised by you in first

❝ response without filing the photocopies in BA dept.


I would go for a central archiving. Both departments are working on the same trial, and you can have a central archive for that trial.

❝ Once again, are dated signatures needed on the photocopy?


If you want to have a copy in the bioanalytical documentation: once again, I would say no need for signatures on the photocopy. The original document will be available if anybody wants to see the source document for any reason.

Regards
Ohlbe
Preet
☆    

2009-03-21 06:06
(5487 d 03:29 ago)

@ Ohlbe
Posting: # 3387
Views: 5,604
 

 Source Document: certified copies

Dear Ohlbe,

Once again thanks a lot. All my doubts are pretty clear. This piece of information definitely going to help us in documentation process. I will share this information with my team mates. :ok:

Warm Regards,
Preet
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