NOTE TO FILE

[gowrisankar]

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Dear Friends,

I want an opinion from all of u that Y NOTE TO FILE IS NEEDED IN CLINICAL RESEARCH?

[ilikecdm]

Note to file is used when we deviate from our SOPs or guidelines designed for project. So in Note to File we document the things which we have not followed. Note to file should be approved from QA and if required from sponsor.

Note to file act as explaination to QA's questions or observations reported in Audit. To avoid remarks from QA, Note to File is created.

I Like CDM

[gowrisankar]

Dear I Like CDM,

Thanks for your explanation.

[dryathish.qa]

Dear Gowrishankar,

Note to file is used to explain a descrepancy or a process that is not usually followed. on such example isas follows. As you all know  Trial Master File (TMF) has to contain many documents. But all the documents can not be filed in single file. So the usual practice is to place some documetns in other seperate file and indicate in the Trial master file with "Note to file" where exactly those other documents are filed. For example correspondences of the study may be too much so that they can not be filed in TMF. In such cases it can be filed in sepearte file and in TMF indicated by a Note to file stating that correspondence related to study is placed in a file by name " whichever name you have given it to that seperate files.

Note to file has to be written and signed by the person who is responsible or involved in the descrepancy. There is no rule like it has to be approved by QA. But it definitely helps the QA to understand the process which may be unclear without Note to file.

An article related to Note to files you can see in the link below..

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=500437


Regards,
Dr.Yathish.S

[pnreddy]

Note to file is one of the elements of good documentation practices. It will avoid many queries by cras and auditors.

[gowrisankar]

Thanks for your explanation dr.yathish and PN

[dryathish.qa]

welcome Gowrishankar

Dr.Yathish.S

[Sushma]

Hi Dr.Yathish,

Thanks for sharing the article. It is a comprehensive write up of one who has experienced and analysed what Note to file is all about.

It is a must to read document for all those invlolved in clinical trials. (My personal suggestion)

As truly quoted, Note to files, in today's situation has been an aid for site personnel as well as the CRA's to document a mistake, which does not serve any purpose.

Use of Note to File has to be very judicious and Not for anything and everything the CRA or site personnel feels like to document to safeguard one's mistake during audit.

Thanks & regards
Sushma

[dryathish.qa]

Dear Sushma,

Thank you and as you told the content of the article definitely shows the experience of the author in this field.

I have heard from many CRCs and CRAs considering the Note ti file as a solution to most of the mistakes. But it is not true. Auditors expect either no mistakes or soutions to mistakes (CAPA) but not quoting the mistakes in a Note to file.


Regards,
Dr.Yathish.S

[karna chary]

I have heard from many CRCs and CRAs considering the Note ti file as a solution to most of the mistakes. But it is not true. Auditors expect either no mistakes or soutions to mistakes (CAPA) but not quoting the mistakes in a Note to file.

hi Dr.yathish.

i didn't understand ur last line in ur erier post.

can u explain clearly.

thanx......