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Investigator Site File Index * denotes document should be retained according to MRC GCP guidelines Section 1: Reference Information 1.1Trial contacts and coordination detailsCopy1.2Trial SummaryCopySection
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How to fill out investigator site file index
01
To fill out investigator site file index, follow these steps:
1. Start by organizing the documents that need to be included in the investigator site file.
02
Create a table of contents that lists all the documents and their corresponding page numbers.
03
Begin filling out the index by listing the document names in alphabetical order.
04
Assign a page number to each document and update the table of contents accordingly.
05
Make sure to include any required signatures or approvals on the corresponding documents.
06
Review the investigator site file index for accuracy and completeness.
07
Make copies of the indexed documents for distribution, if necessary.
Who needs investigator site file index?
01
The investigator site file index is needed by research or clinical trial organizations that conduct studies at multiple sites. It helps in organizing and managing the necessary documents at each site.
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What is investigator site file index?
The investigator site file index is a document that contains a list of all the essential documents and records at an investigator site.
Who is required to file investigator site file index?
The sponsor of the clinical trial is required to file the investigator site file index.
How to fill out investigator site file index?
The investigator site file index should be completed by listing all the necessary documents and records at the investigator site in a detailed manner.
What is the purpose of investigator site file index?
The purpose of the investigator site file index is to provide a quick reference for all the essential documents and records at the investigator site.
What information must be reported on investigator site file index?
The investigator site file index must include details of all essential documents such as the protocol, informed consent forms, and other relevant study documents.
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