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Hi Allison,
Where do you file General documents?
They are not Study Level or Site level documents?
For Ex.
General Product Information
Study Cancellation
Study On Hold
Suspended Study
thanks,
Janna02 Central Trial Documents 02.02 Subject Documentation 02.02.01 Subject Diary To document subject data captured by the subject and external to the CRF (blank forms / templates). “Subject Diary
Subject Diary Review and Approval
Subject Diary Summary of ChangesEx. Document Type
“Dairy Form
Patient Dose Diary-02.02.01
Site coordinator or other staff file in 02.02.02″Janna
”
Hi Leanne,
I think this the correct Zone-
Example of documents:“Example of Documents,
Patient Pre-Screening Call/ Telephone Script
Subject Questionnaire, review and approval any summary of changes
Patients Dose Dairy filled out by site coordinator or other staff02 Central Trial Documents 02.02 Subject Documentation 02.02.02 Subject Questionnaire To capture specific subject related information through a series of questions (blank forms / templates) “Subject Questionnaire
Subject Questionnaire Review and Approval
Subject Questionnaire Summary of Changes
”
Hope this helps!
JannaHi Both,
In my last job.
My Company did not file site-specific SOPs in the sponsor TMF. They should remain at the site and be available upon request as part of site selection, or during an audit or an inspection. Other organizations, maintain one TMF set Per site to maintain site-level documents, so we could technically place the site-specifics SOPs within 01.01.04 if situation arises.Your organization should have a SOP for preparation and maintenance for TMF.
hope this helps!
JannaExample for Non-IP Documents,
Non IP Example of documents (if applicable)
Study Supplies Log
Subject Accountability Log
Other Site Logs06 IP and Trial Supplies 06.01 IP Documentation 06.01.10 IP Return Documentation To record details of returns to/from a distribution center, depot and/or trial site. Examples include courier documentation and packing/ inventory listing. “Acknowledgement of Return
IP Return Documentation
IP Return FormNon-IP-
06 IP and Trial Supplies 06.05 Non-IP Documentation 06.05.03 Non-IP Return Documentation To inventory the returns of certain non-IP supplies needed to fulfill the trial protocol requirements to a distribution center, depot and/or site. Examples include courier documentation and packing/ inventory listing. “Acknowledgement of Return
Non-IP Return Documentation
Non-IP Return Form”Please follow your SOP.
hope this helps!
Janna”
Definitions.
To provide a detailed design framework for
the system(s) used to manage and store
subject/patient data captured via a paper
CRF or eCRF for the specified trial. Not to be
confused with specifications for the Electronic
Data Capture (EDC) system (see 10.04.02).
Reason for change:
Clarification”Hi Istvan,
The TMF RM Document types shows:
“Database RequirementsDatabase Specifications
Coding Approval Document,
Coding Listing Form,
Coding Consistency Report,
Final Coding Listing,”Others,
Database Programming Requirements, Database Design Listing, SAS Dataset Specification, Decoding Request, Randomization Release Request, Request for Access to Randomization (If Applicable to your study)
Please follow your SOPs.
Hope this helps!
JannaHi Istvan,
The TMF RM Document types shows:
“Database RequirementsDatabase Specifications
Coding Approval Document,
Coding Listing Form,
Coding Consistency Report,
Final Coding Listing,”Others,
Database Programming Requirements, Database Design Listing, SAS Dataset Specification, Decoding Request, Randomization Release Request, Request for Access to Randomization (If Applicable to your study)
Please follow your SOPs.
Hope this helps!
JannaHi Nick,
I think it should be filed in TMF for each study.
This is a Study Level document across all studies correct?
Example of documents,
“Acknowledgement of Receipt Protocol Deviation Listing (component of CSR)
Protocol Deviation Report
Waiver Report
Deviation date
PI Signature Date
CRA Signature Date
CM Signature Date”05 Site Management 05.04 Site Management 05.04.06 Protocol Deviations To document non-compliance/ deviations to the protocol. This may also be a consolidated list for a country filed at the country level or a consolidated list for the study filed at the study level. “Protocol Deviations
Protocol Deviation Logs
Protocol Deviation Report
”
Hope this helps!
Janna