Author Topic: Template for Source Document  (Read 3339 times)

0 Members and 1 Guest are viewing this topic.

Offline pritesh09

  • Forum Member
  • Posts: 167
  • Gender: Male
  • Jai Hind
  • Respect: 0
Template for Source Document
« on: Wed, 6 Jan 2010 »
0

CRS

  • *
  • Newbie
  • Posts: 377

  • Thank You
  • -Given: 34
  • -Receive: 167
    • View Profile
    • Email
    • Personal Message (Offline)

Sponsored Links

Dear All,

I am looking for the template for source document.

Most of the CRAs knows that how they review the source documents which written by PI at the site. Here I am planning to have such template where all the information can be cpatured starting from patient's first visit to last (up to SCV).

Waiting for your kind response.

Regards,
Pritesh

Offline vsavitha24

  • CRS Member
  • Loyal Member
  • *
  • Posts: 235
  • Respect: +1
Re: Template for Source Document
« Reply #1 on: Wed, 6 Jan 2010 »
0
Hi Pritesh,

Please find the template for source documents. Hope it was useful for you ...

http://www.visn2.va.gov/apps/visn2shared/research/buf/f_/tools/GCP_Tool_16_Source_Document_Template_Prototype.doc

Regards

Savitha

Offline pritesh09

  • Forum Member
  • Posts: 167
  • Gender: Male
  • Jai Hind
  • Respect: 0
Re: Template for Source Document
« Reply #2 on: Wed, 6 Jan 2010 »
0
Dear Savita,

Thanks a lot for your quick response !!!

I also have got the same thing from Google !!!

Need something different, if you can do for all our friendzzz

Regards,
Pritesh

Offline Sushma

  • Global Moderator
  • Loyal Member
  • *
  • Posts: 1205
  • Gender: Female
  • Respect: +7
Re: Template for Source Document
« Reply #3 on: Thu, 7 Jan 2010 »
0
Dear All,

I am looking for the template for source document.

Most of the CRAs knows that how they review the source documents which written by PI at the site. Here I am planning to have such template where all the information can be cpatured starting from patient's first visit to last (up to SCV).

Waiting for your kind response.

Regards,
Pritesh

Hi Pritesh,

To the best of my knowledge, i guess source documentation depends on the elements of the protocol.

Can you elaborate on your expectation of the template??

Regards
Sushma
Sushma
Disclaimer: All the responses and the postings in this Forum are my personal views and opinion. It does not represent/reflect my company strategies and polices on the same.

Offline pritesh09

  • Forum Member
  • Posts: 167
  • Gender: Male
  • Jai Hind
  • Respect: 0
Re: Template for Source Document
« Reply #4 on: Thu, 7 Jan 2010 »
0

Dear Sushma,

It's good to hear from your side.

As it is concern to the basic OR general protocol requirement.

e.g.
patient first visit
patient history review
PI decides that the patient is eligible for the study
ICF procedures documentation (Depends how you want? some CROs asking for question which was asked by the patient)
screening all procedures
Randomisation
IP administration to all the visits
Follow up visits
close out visits

It is all about the information you want. I can say that it will be the similar to CRF but not CRF.

Queries are welcome.

Regards,
Pritesh

Offline drthakkar

  • Forum Member
  • Posts: 110
  • Respect: 0
Re: Template for Source Document
« Reply #5 on: Thu, 7 Jan 2010 »
0
Hi Pritesh,

Source document template is used by many CROs , just to simplify work for investigators at site and to assure that all things needed by protocol and CRF are captured by Investigator.

I agree with Sushma, it has to be specific to the protocol.

You have to make source document template as per your protocol which helps investigator in documentation and Monitor to review the work at site.

Regards,
Dr. Thakkar

CRS

  • *
  • Newbie
  • Posts: 377

  • Thank You
  • -Given: 34
  • -Receive: 167
    • View Profile
    • Email
    • Personal Message (Offline)

Sponsored Links


 

Related Topics

  Subject / Started by Replies Last post
3 Replies
1218 Views
Last post Mon, 22 Sep 2008
by rockky_b
14 Replies
2234 Views
Last post Wed, 7 Jan 2009
by pritesh09
2 Replies
2281 Views
Last post Tue, 10 Nov 2009
by Sushma




SMF 2.0.3 | SMF © 2011, Simple Machines

SimplePortal 2.3.3 © 2008-2010, SimplePortal