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Soft-lock/Unlock form or form record

In EDC, CRFs or individual records of the log forms that are already reviewed by the data manager (DM) and are ready for further review—clinical research associate (CRA), principal investigator (PI), or else—can be soft-locked. The soft lock is required to prevent any actions or amendments to the data already validated by DM. Locking the form is important to avoid intended or accidental data distortion.

However, if there is a need to perform some eligible changes to the CRF data, the form can be temporarily unlocked.

Furthermore, when you configure the study-level settings, you can set the conditions for the Softlock feature. These conditions ensure that you can only soft-lock forms and records when such conditions are met, providing an additional tier of scrutiny. This prevents users from accidentally soft-locking forms without meeting the predefined conditions, such as required reviews and resolved queries.

Important

For the subjects whose site was changed, the PI of the current site cannot soft-lock the forms and records already locked at the previous site.

To soft-lock or unlock a form or form record

  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. In the Subject List table that appears, select the ID of the subject to open their Visit Overview page.

    Selecting database ID
    Figure 2. Selecting database ID

  4. On the Visit Overview page that opens, on the left, a panel with all subject visits is displayed. Expand the visit and select the form that you want to soft-lock or unlock.

    Accessing form to soft-lock
    Figure 3. Accessing form to soft-lock

    Tip

    Note that forms available for soft-lock have the DM Review dm_review_icon.png status and those available for unlock have the Softlocked softlocked_icon.png status.

  5. Now access the form soft-lock functionality in your preferred way as follows.

Once done, the form is soft-locked or unlocked based on your performed action. Once all the records of the log form are soft-locked, the log form itself becomes soft-locked automatically.

Tip

In EDC, you can enable the functionality for the clinical research coordinator (CRC) to add new records to the soft-locked log forms. This is needed, for instance, to avoid delays in recording adverse event details for the subject whose form is already soft-locked, however, the follow-up data becomes available.

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.

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.