Use the following table when creating a File Review Template.
Field
Description
Action
| Name | The name of your File Review Template. Note: This will display each time you create a file review from this template. | Enter a name in the field. |
| Review Type | The type of file review provided from the File Review Types Data Dictionary. | Select one of the File Review Types. |
| Description | (Optional) A description of the template purpose. | Enter a description. |
| Minimum Sampling Percentage | The minimum percentage of study items to include as review items in file reviews created from this template. | Enter the minimum percentage. |
| Apply Sampling Percentage Before or After All Filtering | Filtering mechanism to determine the number of review items for reach file review. | Select one of the following: Before: Mandatory items are counted towards the sample size. After: Mandatory items are not counted towards the sample size. |
| Sample Size Parameters | Parameters for calculating the sample size percentage for your file review template. | Select the button and enter your calculation. For more information on sample size calculation, see here. |
| Review Manager Groups | The group of users who can create and manage File Reviews of this template. | Click Select Groups. In the Groups & Roles screen, select the check box for each group to specify. Use the search and filter fields on the left to reduce the list as needed. |
| Review Participant Groups | The group of users who can evaluate review items for this template. | See Above. |
| Review Reader Groups | The group of users who can view File Reviews created from this template. | See Above. |
| Risk Level | The specified document type risk level. | Set the risk level between 1 (low) to 10 (high). |
| Mandatory Document Types | The required document types that are added to the file review. Note: These documents can not be deleted during a review. | Click Select Document Types, then choose the documents from the TMF Master List. Use the search and filter fields on the left to reduce the list as needed. |
| Excluded Document Types | The document types to exclude when performing the file review. | See Above. |
| Document Selection | All Documents – Includes all finalized documents that satisfy other conditions for the template. All Unreviewed Documents – Includes all documents that satisfy other conditions for the template AND that have not been included in another File Review of the same type. All Unreviewed Documents Within Specified Period – Includes all finalized documents that satisfy other conditions for the template, have not been included in another File Review of the same type, AND have a Finalization Date that falls within the dates of the File Review. Note: The dates of the File Review are specified during File Review creation. | Select All Documents, All Unreviewed Documents, or All Unreviewed Documents Within Specified Period. |
| Include all Study Items satisfied without content | No Empty Study Items – Excludes all empty Study Items from File Reviews All Empty Study Items – Includes all empty Study Items that satisfy other conditions for the template. All Unreviewed Empty Study Items – Includes all empty Study Items that satisfy other conditions for the template AND that have not been included in another File Review of the same type. All Unreviewed Empty Study Items Within Specified Period – Includes all empty Study Items that satisfy other conditions for the template, have not been included in another File Review of the same type, AND have a Creation Date that falls within the dates of the File Review. Note: Available if All Unreviewed Documents Within Specified Period was selected in the Document Selection field. | Select No Empty Study Items, All Empty Study Items, All Unreviewed Empty Study Items, or All Unreviewed Empty Study Items within a Specified Date. |
| Country | Used to control selection of country and site level study items. Note: Using a country filter does not prevent selection of enterprise, program, or study level study items | Select one or multiple countries. |
| Site Status | Used to control the selection of site level study items by status. | Select a site status from the dropdown. |
| Site | Used to control the selection of site level study items by site. | Select your site from the dropdown. |
| Document Owner | Filter study items by document owner. | Select one or multiple document owners from the dropdown. |
| Document Submitter | Filter study items by document submitter. | Select one or multiple document submitters from the dropdown. |
| Exclude Unblinded | The option to exclude unblinded documents from the file review. | Select Yes or No. |
| Non Document Items | Review Items that are not related to specific documents (e.g., Check Correspondence). The list of non-document review items is provided from the File Review Non Document Review Items dictionary. | Select one or more non-document items. |
