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Soft-lock/Unlock site

EDC is your clinical database for recording subject data collected in the course of your study at patient visits through case report forms (CRFs). Once all the data is entered into CRFs, it undergoes various reviews to ensure its accuracy, validity, compliance with established industry standards, and so on. Usually, a review cycle involves multiple stages, such as data manager (DM) review, clinical research associate (CRA) review, principal investigator (PI) review, safety review, and more.

In the EDC application, to ensure that data is not modified between different review stages, there is an option to soft-lock individual forms or an entire site, if all its forms are in a review cycle. Since the data that is soft-locked cannot be amended, and there can be occasions when some eligible changes are required, in EDC, there is an option to temporarily unlock a site.

Furthermore, when you configure study-level setting, you can set the conditions for the Softlock feature. These conditions ensure that the you can only soft-lock sites when all the conditions that you set are met. Users will not be able to soft-lock sites accidentally or without the predefined conditions, including required reviews and resolved queries.

Important

A site can only be soft-locked when all visits and forms within that particular site adhere to the conditions set for the Softlock feature.

The soft-lock functionality can be disabled for a site with no active subjects by managing the site-level settings.

To soft-lock or unlock a site

  1. In the EDC application header, select the DATA ENTRY tab.

  2. On the site list page that opens, select the tile representing the site with which you want to work.

    Selecting site tile
    Figure 1. Selecting site tile

  3. On the Subject List page that opens, select Softlock.png to lock the unlocked site or unsoftlock.png to unlock the locked site.

    Soft-locking or unlocking a site
    Figure 2. Soft-locking or unlocking a site

    Important

    If the site that you want to unlock is already signed, you need to unsign the site for the Unsoftlock option to become available.

  4. In the confirmation dialog that appears, select confirm_button.png to implement your changes.

    Confirming site soft-lock or unlock
    Figure 3. Confirming site soft-lock or unlock

Once confirmed, the site is either soft-locked or unlocked depending on your selected action.

See also
In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

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 person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.