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Managing study and site-level setting

In a clinical trial, the process of data collection should be a unified procedure that requires some preconfigured parameters for all sites.

In EDC, you can control if there are stages of data soft and hard lock as a part of the review and approval process and whether the collected data must be signed by the principal investigator (PI) as a mandatory validation step.

You can configure study-level settings related to the soft lock, hard lock, and PI signature features that will affect all the sites by default. However, if the site requires it, you can configure the site settings individually.

Manage study-level settings

In EDC, you can configure study-level settings of CRF and visit statuses that are applicable to all the study sites. These settings include:

  • CRF status transition configuration. With this option you can control which operations performed in the eClinical applications or external systems can affect the CRF review status in EDC.

    For instance, if the CRF is DM Reviewed and one of the enabled changes occurs, such as lab data sync or subject randomization data changes, then the DM Reviewed status is canceled, and the CRF becomes Completed.

  • Soft lock logic. With this option you can set conditions under which the study is locked to prevent unauthorized modifications and introduce exceptions if required.

    For instance, you want the CRFs to be locked to prevent them from any editing, however, you still allow for queries to be opened for soft-locked data to be able to address any discrepancies.

  • PI signature requirements. With this option you can specify if the principal investigator (PI) signature is required at sites and introduce exceptions for data modifications in signed CRFs if required.

    For instance, PI signature is required to confirm CRF data validation, however, you still allow DM review and SDV to be performed after the PI signature is in place for more flexibility of the study staff performance.

Important

For the hierarchical study design, you need to configure the study-level settings individually for the master study and its substudies.

To manage study-level settings

  1. In the EDC application header, select the STUDY INFO tab.

  2. From the left pane, select Study Information.

    Accessing study information management
    Figure 1. Accessing study information management

  3. From the contents panel, select the Status Configuration tab.

  4. On the page that opens, configure your study-level settings as explained in the following table.

    Configuring study-level settings
    Figure 2. Configuring study-level settings

    Element

    Details

    CRF Status Transition Configuration

    External Data Synchronization

    Site and Country Management Update

    Turn the toggle on or off to allow or prohibit the changes of site or country details in CTMS affect the related CRF review status in EDC.

    Randomization and Drug Assignment Operations

    Turn the toggle on or off to allow or prohibit the changes of subject randomization or treatment assignment data in IWRS affect the related CRF review status in EDC.

    Clinical Image Data Synchronization

    Turn the toggle on or off to allow or prohibit the changes performed to medical images via IMAGING affect the related CRF review status in EDC.

    Third-party System Data Synchronization

    Turn the toggle on or off to allow or prohibit the changes triggered by integrations with external systems affect the related CRF review status in EDC.

    Internal Data Synchronization

    Data-Driven Form Updates

    Turn the toggle on or off to allow or prohibit the changes in EDC, such as CRF version upgrade or else, affect the related CRF review status.

    Lab Data Synchronization

    Turn the toggle on or off to allow or prohibit the changes in lab data configurations in EDC to affect the related CRF review status.

    Study Level Setting

    Softlock

    Request Softlock

    Turn on the toggle if you want the sites to request soft lock from a designated user between the data review stages.

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

    Select the condition you want to achieve before softlock

    DM Reviewed

    Select this checkbox to require a data manager (DM) review of the study data before the designated user can soft lock the study.

    Safety Reviewed

    Select this checkbox to require a safety review of the study data before the designated user can soft lock the study.

    SDV Completed

    Select this checkbox to require a Source Data Verification (SDV) review of the study data before the designated user can soft lock the study.

    No Unresolved Query

    Select this checkbox if you want all study-level queries to be resolved before the designated user can soft lock the study.

    Choose operations that can be performed under this status

    Add record to form

    Select this checkbox so the designated user can add records to forms when the form is soft-locked.

    If the parent-level subject, site, or study is soft-locked, users cannot add records to forms even if you select the Add record to form checkbox.

    Edit form data

    Select this checkbox so the designated user can edit data in the form that is soft-locked.

    DM Reviewed

    Select this checkbox to allow the DM review to be performed after the form is soft-locked.

    This option becomes available if DM Reviewed checkbox is not selected as a condition to be achieved before the soft-lock.

    SDV

    Select this checkbox to allow the SDV review to be performed after the form is soft-locked.

    This option becomes available if SDV Completed checkbox is not selected as a condition to be achieved before the soft-lock.

    Safety Review

    Select this checkbox to allow the safety review to be performed after the form is soft-locked.

    This option becomes available if Safety Reviewed checkbox is not selected as a condition to be achieved before the soft-lock.

    Open Query

    Select this checkbox to allow opening new queries after the form is soft-locked.

    This option becomes available if No Unresolved Query checkbox is not selected as a condition to be achieved before the soft-lock.

    PI Signature

    Request PI Signature

    Turn on the toggle if you want the site to request a PI signature to confirm data validation at the site.

    You can also configure the setting for PI signature so the designated personnel can still apply their signature without soft-locking the site. Before doing so, ensure that the site meets all the predefined conditions for the Softlock feature, such as required reviews and resolved queries.

    Independent/Related

    Use the buttons to configure the PI signature setting as follows:

    • Independent: select to make the PI signature option available at any status of the CRF except for Initial (when the data entry has not started yet); this makes it possible for the PI to sign the form disregarding other roles' signatures or the lock status of the CRF.

    • Related: select to make the PI signature option only available upon the completion of the conditions that must be achieved before the soft lock and actual soft-locking of the CRF (if not set to skip the locking).

    Auto-Sign Site Upon All Subject Sign-Off

    Select this checkbox to automatically sign the site once all the subjects at the site have the PI signature. If cleared, the PI must sign the site separately when needed.

    Allow to skip softlock

    Select this checkbox to allow designated users to skip soft-locking the study when they apply their PI signature at the site.

    This checkbox is only available for the Related form dependency setting.

    Choose operations that can be performed under this status

    Add record to form

    Select this checkbox so the designated users can add records to forms when they apply their PI signature at the site.

    For the Related form dependency, if the parent-level subject, site, or study is signed, users cannot add records to forms even if you select the Add record to form checkbox.

    For the Independent form dependency, adding a record to a form that is signed or whose parent-level subject, site, or study is signed, removes the signature and the PI must sign the respective entities again.

    Edit form data

    Select this checkbox so the designated users can edit form data when they apply their PI signature at the site.

    Unsoftlock / Softlock

    Select this checkbox so the designated users can soft-lock or unlock the study when they apply their PI signature at the site.

    This checkbox is only available for the Independent form dependency setting.

    Unsoftlock

    Select this checkbox so the designated users can unlock the study when they apply their PI signature at the site.

    This checkbox is only available for the Related form dependency setting.

    DM Review

    Select this checkbox to allow the DM review to be performed after the form is signed by the PI.

    SDV

    Select this checkbox to allow the SDV review to be performed after the form is signed by the PI.

    Safety Review

    Select this checkbox to allow the safety review to be performed after the form is signed by the PI.

    Open Query/Comment

    Select this checkbox to allow opening new queries and adding comments after the form is signed by the PI.

    This checkbox is only available for the Independent form dependency setting.

    Hardlock Applicable Level

    Site

    Select this checkbox if you want to allow the hard-lock of the study sites.

    Hard-locking the site means ceasing data entry and amendment for all the subjects and their forms at the specific site.

    Subject

    Select this checkbox if you want to allow the hard-lock of the subjects of the study.

    Hard-locking the subject means ceasing data entry and amendment for all the visits and forms of the specific subject.

    Visit & Form

    Select this checkbox if you want to allow the hard-lock of the visits and forms of the study.

    Hard-locking the visit or form means ceasing data entry and amendment for all the forms of the specific visit or the records of the specific form.

    SAVE

    Select save_button_red.png to implement the changes.

  5. In the confirmation dialog that appears if your changes affect the current data entry flow, select confirm_button_white_red.png to proceed with your action.

    Confirming status configuration change
    Figure 3. Confirming status configuration change

Once saved and confirmed, the study follows the set configurations of soft and hard locking data and requesting the PI's signature.

Manage site-level settings

In EDC, for each site, you can configure individual settings related to soft lock, hard lock, and PI signature features. These settings can differ from those configured at the study level and applied to the sites without individual configurations.

Important

The site-level configuration does not affect the default study-level configuration for the soft lock, hard lock, and PI signature functionalities.

To manage site-level settings

  1. In the EDC application header, select the STUDY INFO tab.

  2. From the left pane, select Study Information.

    Accessing study information management
    Figure 1. Accessing study information management

  3. On the page that opens, select the Status Configuration tab.

  4. On the page that opens, in the Site Level Setting section, select one of the following:

    • New Item add_new_icon.png: to add a new site-level setting of the soft lock, hard lock, and PI signature.

    • Edit pencil_icon.png: to update the soft lock, hard lock, and PI signature settings for the site.

    Adding or editing site-level settings
    Figure 2. Adding or editing site-level settings

  5. In the Site Details panel that opens, configure the site-level settings as explained in the following table.

    Configuring site-level settings
    Figure 3. Configuring site-level settings

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Site Code*

    Select the unique code of the site for which you want to configure the site-level settings.

    You can only select the site code when you're adding a new site-level setting.

    Request Softlock

    Turn on this toggle if you want the sites to request soft lock from a designated user between the data review stages.

    This toggle is automatically turned on and cannot be turned off if the site already has one or more active subjects.

    Select the condition you want to achieve before softlock

    DM Reviewed

    Select this checkbox to require a data manager (DM) review of the study data before the designated user can soft lock the study.

    CRA Reviewed

    Select this checkbox to require a clinical research associate (CRA) review of the study data before the designated user can soft lock the study.

    Safety Reviewed

    Select this checkbox to require a safety review of the study data before the designated user can soft lock the study.

    SDV Completed

    Select this checkbox to require a Source Data Verification (SDV) review of the study data before the designated user can soft lock the study.

    No Unresolved Query

    Select this checkbox if you want all study-level queries to be resolved before the designated user can soft lock the study.

    Choose operations that can be performed under this status

    Add record to form

    Select this checkbox so the designated user can add records to forms when the study is soft-locked.

    If the parent-level subject, site, or study is soft-locked, users cannot add records to forms even if you select the Add record to form checkbox.

    Edit form data

    Select this checkbox so the designated user can edit form data when the study is soft-locked.

    Request PI Signature

    Turn on the toggle if you want the site to request a PI signature to confirm data validation at the site.

    You can also configure the setting for PI signature so the designated personnel can still apply their signature without soft-locking the site. Before doing so, ensure that the site meets all the predefined conditions for the Softlock feature, such as required reviews and resolved queries.

    Select settings for PI signature workflow

    Independent/Related

    Represents one of the following:

    • Independent: if selected, the PI signature option is available at any status of the CRF except for Initial (when the data entry has not started yet); this makes it possible for the PI to sign the form disregarding other roles' signatures or the lock status of the CRF.

    • Related: if selected, the PI signature option only available upon the completion of the conditions that must be achieved before the soft lock and actual soft-locking of the CRF (if not set to skip the locking).

    This setting follows the study-level dependency configuration and cannot be manually changed at the site level.

    Auto-Sign Site Upon All Subject Sign-Off

    Select this checkbox to automatically sign the site once all the subjects at the site have the PI signature. If cleared, the PI must sign the site separately when needed.

    Allow to skip softlock

    Select this checkbox to allow designated users to skip soft-locking the study when they apply their PI signature at the site.

    If the parent-level subject, site, or study is signed, users cannot add records to forms even if you select the Add record to form checkbox.

    This checkbox is only available for the Related form dependency setting.

    Choose operations that can be performed under this status

    Add record to form

    Select this checkbox so the designated users can add records to forms when they apply their PI signature at the site.

    Edit form data

    Select this checkbox so the designated users can edit form data when they apply their PI signature at the site.

    Unsoftlock / Softlock

    Select this checkbox so the designated users can soft-lock or unlock the study when they apply their PI signature at the site.

    This checkbox is only available for the Independent form dependency setting.

    Unsoftlock

    Select this checkbox so the designated users can unlock the study when they apply their PI signature at the site.

    This checkbox is only available for the Related form dependency setting.

    CRA Review / Cancel CRA Review

    Select this checkbox to allow the CRA's review to be performed or cancelled (if already done) after the form is signed by the PI.

    DM Review / Cancel DM Review

    Select this checkbox to allow the DM's review to be performed or cancelled (if already done) after the form is signed by the PI.

    SDV / Cancel SDV

    Select this checkbox to allow the SDV to be performed or cancelled (if already done) after the form is signed by the PI.

    Safety Review / Cancel Safety Review

    Select this checkbox to allow the safety review to be performed or cancelled (if already done) after the form is signed by the PI.

    Open Query / Comment

    Select this checkbox to allow opening new queries and adding comments after the form is signed by the PI.

    This checkbox is only available for the Independent form dependency setting.

    Hardlock Applicable Level

    Site

    Select this checkbox if you want to enable the hard-lock on the site level.

    Subject

    Select this checkbox if you want to enable the hard-lock on the subject level.

    Visit & Form

    Select this checkbox if you want to enable the hard-lock on the visit level.

    SAVE

    Select save_button_red.png to implement the changes.

    CANCEL

    Select cancel_button_white_blue.png to dismiss the changes without saving.

  6. In the confirmation dialog that appears if your changes affect the current data entry flow, select confirm_button_white_red.png to proceed with your action.

    Confirming status configuration change
    Figure 4. Confirming status configuration change

Once saved and confirmed, the site follows the set configurations of soft and hard locking data and requesting the PI's signature.

In this section:

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.

CRF

An occurrence in a clinical trial in which the subject comes to a site to receive treatment, undergo some tests, or complete other required procedures.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

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 process of ensuring data accuracy and integrity within a clinical trial. SDV involves the review and comparison of data recorded in the source documents against the data captured on the case report forms (CRFs). During SDV, a trained monitor or clinical research associate (CRA) compares the source data to the CRFs to identify any discrepancies or errors. They may review laboratory results, medical history, adverse event records, and other relevant information. Discrepancies found during SDV are usually documented and resolved through data clarification or query processes with the site personnel responsible for data collection.

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.

An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.

Get to know all the possibilities of the app with the comprehensive CTMS User Guide.

An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.

Get to know all the possibilities of the app with the comprehensive IWRS User Guide.

An eClinical application that represents a hub for uploading, storing, and managing medical images, such as MRI, CT scans, and X-rays, collected from trial participants across various sites while facilitating quality checks to ensure compliance with regulatory and study protocol requirements.

Source Data Verification (SDV)clinical research associate (CRA)

A review of data collected via CRFs, especially those related to adverse events and serious adverse events data records. The safety review is intended to identify any risks related to subject safety. This review can be done by physicians, pharmacovigilance teams, or other dedicated personnel as per study protocol.

Source Data Verification (SDV)

In eClinical, queries are created to ask a question or get feedback from a designated system user on a particular data item. There are two types of queries in the system:

  • Manual query: these are created by the system users and assigned to responsible users to address the issues and either correct them or confirm the data's accuracy.

  • System query: these are generated automatically by the system and require user interaction to manage and resolve them.