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Review file lifecycle for document warehouse

In eTMF, the Document Warehouse tab is mainly used for the temporary storage of some unorganized files so that, upon request, they can be organized by data managers (DM) and other accountable individuals per DIA RM and uploaded to the Essential Documents storage.

For traceability of all files, you can review the comprehensive file lifecycle—a log on all actions with files from their upload to Document Warehouse to the current time.

To review the file lifecycle for the document warehouse

  1. In the eTMF application header, select the TMF tab.

  2. In the Study List that opens, from the table, select the name of the study for which you want to access the document warehouse.

    Selecting study
    Figure 1. Selecting study

  3. From the left pane, select the Document Warehouse subtab. If required, from the study selection field, you can change another study.

    Accessing document warehouse and study
    Figure 2. Accessing document warehouse and study

  4. From the workspace toolbar, select Lifecycle lifecycle_icon.png.

    Accessing file lifecycle in document warehouse
    Figure 3. Accessing file lifecycle in document warehouse

  5. On the Lifecycle page that opens, review the complete history of operations performed with the files currently stored in the document warehouse.

    Reviewing file lifecycle in document warehouse
    Figure 4. Reviewing file lifecycle in document warehouse

You have reviewed the file lifecycle. Select Back to List back_arrow_icon.png to return to the Document Warehouse file storage.

In this section:

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A model for organizations from DIA that helps the organizations to effectively compile the minimum list of essential documents to ensure the compliance of the investigator, sponsor, and monitor with the industry standards of good clinical practice (GCP) and with the regulatory requirements.