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Script-generated potential PD

The potential protocol deviation (PD) is a situation identified during a clinical trial that could lead to a violation of the study protocol if not addressed, but has not yet actually occurred. It represents a risk or near miss—something that, if left uncorrected, might result in an actual deviation from the protocol requirements.

For efficient management of a potential PD, it must be identified and recorded by a clinical research associate or data manager. In CTMS, you can either create the potential PD records manually or generate them using scripts. A script is an uploaded R file containing predefined specifications that automatically generate potential protocol deviation records in the system based on the rules defined within it.

In Study management > Script-generated Reports, you upload this script file as well as indicate the eTMF location of the CSV file that contains the potential PD records. Once the script is run in the Script-generated Reports tab, the corresponding potential PD records are populated under Potential PDs Generated by Script.

Script-generated potential PD records
Figure 1. Script-generated potential PD records

After the potential PD records are generated from the script, you can perform various actions to them as explained in the following sections:

Submit script-generated potential PD

The R script-generated potential protocol deviation (PD) records via Script-generated Reports must be submitted to reviewers for their feedback and approval. The potential protocol deviation (PD) is a situation identified during a clinical trial that could lead to a violation of the study protocol if not addressed, but has not yet actually occurred.

To submit the script-generated potential PD

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, select Protocol Deviation > Potential PDs Generated by Script.

    Accessing script-generated potential PDs
    Figure 3. Accessing script-generated potential PDs

  3. On the page that opens, select a tab depending on the one that contains the required potential PD records.

    Tip

    In Script-generated Reports, you can create multiple potential PD reports using R scripts. Each time a script is run, the system generates a new tab named after the report, which displays the corresponding potential PD records.

  4. In the table that displays the records, next to the required potential PD record, from the Action(s) column, select More more_icon.png > Submit send_icon.png.

    Selecting to submit potential PD record
    Figure 4. Selecting to submit potential PD record

    Tip

    Above the table, use the toggles and filter buttons as needed:

    • Filter buttons: use the available filter buttons, such as Pending Review, Data Entry Completed, and so on, to locate the needed records faster.

    • Only Show Rejected Items: turn this toggle on to show only the records rejected upon audit; turn the toggle off to show all records.

    • Only My Pending Review Items: turn this toggle on to show only the records assigned to you for review and approval and awaiting your audit; turn the toggle off to show all records.

  5. In the dialog that appears, enter the submission details as explained in the following table.

    Important

    Note that the fields in this dialog may vary based on the tasks included in the associated workflow. For instance, this dialog may show an additional field to enter the details of a cosignee if the associated workflow includes the Co-sign node.

    Entering submission details
    Figure 5. Entering submission details

    Element

    Details

    Tabs

    • Operation History. Displays the history of the actions performed to the record as well as the username of the person who performed the action, the date and time at which the action was performed, and the role of the user.

    • Workflow. Shows the workflow linked to the potential PD, including the most recently completed stage and the next stages to be carried out.

    Due Date of Next Work Step

    Select the date by which you are expecting the user to review the potential PD record so that the workflow is moved to the next stage.

    Comment

    Enter a comment providing any additional details about the submitted potential PD record to the reviewer.

    SUBMIT

    Select submit_button_red_white.png to save your changes and submit the potential PD record.

    CANCEL

    Select cancel_button_white_blue.png to dismiss the submission process without saving.

Once submitted, the potential PD record is sent to the reviewer (their role or user name) assigned in the corresponding workflow step.

Audit script-generated potential PD

The R script-generated potential protocol deviation (PD) records via Script-generated Reports must be audited by a reviewer after they are submitted for a review. The potential protocol deviation (PD) is a situation identified during a clinical trial that could lead to a violation of the study protocol if not addressed, but has not yet actually occurred.

To audit the script-generated potential PD

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, select Protocol Deviation > Potential PDs Generated by Script.

    Accessing script-generated potential PDs
    Figure 3. Accessing script-generated potential PDs

  3. On the page that opens, select a tab depending on the one that contains the required potential PD records.

    Tip

    In Script-generated Reports, you can create multiple potential PD reports using R scripts. Each time a script is run, the system generates a new tab named after the report, which displays the corresponding potential PD records.

  4. On the page that opens, audit the script-generated potential PD as follows.

After the script-generated potential PD has been audited, you can push the submitted record to the finalized PD records or work on the unsubmitted and rejected potential PDs as needed.

Trigger workflow for script-generated potential PD

After a script-generated potential protocol deviation record has been submitted for review and audited, you can trigger the workflow again to reinitiate the submission stage for another review. The potential protocol deviation (PD) is a situation identified during a clinical trial that could lead to a violation of the study protocol if not addressed, but has not yet actually occurred. These potential PD records can be automatically generated by running an R script via Script-generated Reports.

You may want to trigger the associated workflow's review and approval stage to ensure the reviewers are informed of the changes or updates that may have been introduced in the PD records if the source file in eTMF has been updated.

To trigger the workflow for script-generated potential PD

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, select Protocol Deviation > Potential PDs Generated by Script.

    Accessing script-generated potential PDs
    Figure 3. Accessing script-generated potential PDs

  3. On the page that opens, select a tab depending on the one that contains the required potential PD records.

    Tip

    In Script-generated Reports, you can create multiple potential PD reports using R scripts. Each time a script is run, the system generates a new tab named after the report, which displays the corresponding potential PD records.

  4. In the table that displays the records, next to the required potential PD record, from the Action(s) column, select More more_icon.png > Trigger Workflow workflow_trigger_icon.png.

    Selecting to trigger workflow for potential PD record
    Figure 4. Selecting to trigger workflow for potential PD record

    Tip

    Above the table, use the toggles and filter buttons as needed:

    • Filter buttons: use the available filter buttons, such as Pending Review, Data Entry Completed, and so on, to locate the needed records faster.

    • Only Show Rejected Items: turn this toggle on to show only the records rejected upon audit; turn the toggle off to show all records.

    • Only My Pending Review Items: turn this toggle on to show only the records assigned to you for review and approval and awaiting your audit; turn the toggle off to show all records.

  5. In the dialog that appears, submit the potential PD to trigger the workflow as explained in the following table.

    Important

    Note that the fields in this dialog may vary based on the tasks included in the associated workflow. For instance, this dialog may show an additional field to enter the details of a cosignee if the associated workflow includes the Co-sign node.

    Submitting to trigger workflow
    Figure 5. Submitting to trigger workflow

    Element

    Details

    Tabs

    • Operation History. Displays the history of the actions performed to the record as well as the username of the person who performed the action, the date and time at which the action was performed, and the role of the user.

    • Workflow. Shows the workflow linked to the potential PD, including the most recently completed stage and the next stages to be carried out.

    Due Date of Next Work Step

    Select the date by which you are expecting the user to review the potential PD record so that the workflow is moved to the next stage.

    Comment

    Enter a comment providing any additional details about the submitted potential PD record to the reviewer.

    SUBMIT

    Select submit_button_red_white.png to save your changes and submit the potential PD record.

    CANCEL

    Select cancel_button_white_blue.png to dismiss the submission process without saving.

Once submitted, the review and approval process for the potential PD record can be initiated again.

Push script-generated potential PD to PD record

When the R script-generated potential protocol deviation (PD) records are approved, they can be pushed to the actual or finalized PD records. The potential protocol deviation (PD) is a situation identified during a clinical trial that could lead to a violation of the study protocol if not addressed, but has not yet actually occurred. These potential PD records can be automatically generated by running an R script via Script-generated Reports.

You push the potential PD records to the finalized PD records to indicate that they have actually occurred in a clinical trial or maybe you are instructed to push the records by a clinical research associate or data manager as per the study protocol requirements.

To push the script-generated potential PD to PD record

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, select Protocol Deviation > Potential PDs Generated by Script.

    Accessing script-generated potential PDs
    Figure 3. Accessing script-generated potential PDs

  3. On the page that opens, select a tab depending on the one that contains the required potential PD records.

    Tip

    In Script-generated Reports, you can create multiple potential PD reports using R scripts. Each time a script is run, the system generates a new tab named after the report, which displays the corresponding potential PD records.

  4. In the table that displays the records, push the records as follows.

    Tip

    Above the table, use the toggles and filter buttons as needed:

    • Filter buttons: use the available filter buttons, such as Pending Review, Data Entry Completed, and so on, to locate the needed records faster.

    • Only Show Rejected Items: turn this toggle on to show only the records rejected upon audit; turn the toggle off to show all records.

    • Only My Pending Review Items: turn this toggle on to show only the records assigned to you for review and approval and awaiting your audit; turn the toggle off to show all records.

Once selected, the script-generated potential PD records are added to the actual and finalized PD records. In the table displaying the script-generated potential PD records, in the PD Record ID column, you can select the hyperlink to access the pushed script-generated potential PD record in the actual PD records table.

Selecting to access actual PD record
Figure 6. Selecting to access actual PD record

Recall pushed script-generated potential PD

After pushing the R script–generated potential protocol deviation (PD) records to the finalized PD records, you can recall them to remove them from the finalized list and return them to the Potential PDs Generated by Script tab. A potential PD is a situation identified during a clinical trial that could lead to a protocol violation if not addressed but has not yet occurred. These records can be automatically created by running an R script through Script-generated Reports.

You may recall pushed potential PD records if you need to restart the review and approval process, or if the record was pushed by mistake and needs to be removed from the finalized PD list.

To recall the pushed script-generated potential PD

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, select Protocol Deviation > Potential PDs Generated by Script.

    Accessing script-generated potential PDs
    Figure 3. Accessing script-generated potential PDs

  3. On the page that opens, select a tab depending on the one that contains the required potential PD records.

    Tip

    In Script-generated Reports, you can create multiple potential PD reports using R scripts. Each time a script is run, the system generates a new tab named after the report, which displays the corresponding potential PD records.

  4. In the table that displays the records, next to the required potential PD record, from the Action(s) column, select More more_icon.png > Recall Recall_icon.png.

    Selecting to recall pushed potential PD record
    Figure 4. Selecting to recall pushed potential PD record

    Tip

    Above the table, use the toggles and filter buttons as needed:

    • Filter buttons: use the available filter buttons, such as Pending Review, Data Entry Completed, and so on, to locate the needed records faster.

    • Only Show Rejected Items: turn this toggle on to show only the records rejected upon audit; turn the toggle off to show all records.

    • Only My Pending Review Items: turn this toggle on to show only the records assigned to you for review and approval and awaiting your audit; turn the toggle off to show all records.

  5. In the dialog that opens, enter the details to recall the record as explained in the following table.

    Recalling pushed script-generated PD record
    Figure 5. Recalling pushed script-generated PD record

    Tip

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

    Element

    Details

    Potential PD Record ID

    Represents the record ID in Potential PDs Generated by Script.

    Recall Reason*

    Enter the reason for recalling the pushed potential PD record.

    Delete the Related PD Record

    Turn the toggle on if you want to delete the record from the finalized PD records and only retain it under the Potential PDs Generated by Script tab.

    Otherwise, the record is maintained in both finalized PD records and under Potential PDs Generated by Script.

    SAVE

    Select save_button.png to implement your changes.

    CANCEL

    Select cancel_button_white_blue.png to dismiss your changes without saving.

Once saved, the script-generated potential PD record is recalled from the finalized PD records. You can now proceed with submitting the record again for review.

Analyze data change history of script-generated potential PD

In CTMS, you can review the complete history of changes made to potential protocol deviation (PD) records generated through R scripts. The potential protocol deviation (PD) is a situation identified during a clinical trial that could lead to a violation of the study protocol if not addressed, but has not yet actually occurred. These potential PD records can be automatically generated by running an R script via Script-generated Reports.

Analyzing the history provides visibility into what data was modified, when the changes occurred, and by whom, ensuring traceability and compliance throughout the review process.

To analyze the data change history of a script-generated potential PD

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, select Protocol Deviation > Potential PDs Generated by Script.

    Accessing script-generated potential PDs
    Figure 3. Accessing script-generated potential PDs

  3. On the page that opens, select a tab depending on the one that contains the required potential PD records.

    Tip

    In Script-generated Reports, you can create multiple potential PD reports using R scripts. Each time a script is run, the system generates a new tab named after the report, which displays the corresponding potential PD records.

  4. In the table that displays the records, from the workspace toolbar, select Data Change History history_icon.png.

    Accessing data change history of potential PD
    Figure 4. Accessing data change history of potential PD

    Tip

    Above the table, use the toggles and filter buttons as needed:

    • Filter buttons: use the available filter buttons, such as Pending Review, Data Entry Completed, and so on, to locate the needed records faster.

    • Only Show Rejected Items: turn this toggle on to show only the records rejected upon audit; turn the toggle off to show all records.

    • Only My Pending Review Items: turn this toggle on to show only the records assigned to you for review and approval and awaiting your audit; turn the toggle off to show all records.

  5. On the page that opens, analyze the history of all the changes introduced to the script-generated potential PD records listed in a table.

    Analyzing data change history of potential PD
    Figure 5. Analyzing data change history of potential PD

  6. If required, next to a particular data row, from the Action(s) column, select Audit approve_icon.png.

  7. In the dialog that opens, analyze the change history of a particular row item in the tabs as follows:

    • Operation History. Displays the history of the actions performed to the data record as well as the username of the person who performed the action, the date and time at which the action was performed, and the role of the user.

    • Workflow. Shows the workflow linked to the potential PD, including the most recently completed stage and the next stages to be carried out.

    Auditing specific data row in potential PD
    Figure 6. Auditing specific data row in potential PD

After you have analyzed the changes, you can return to the script-generated potential PD records and proceed with configurations as needed.

Analyze mail history of script-generated potential PD

The mail history of the script-generated potential PD provides a record of all email communications related to the potential PD records. The potential protocol deviation (PD) is a situation identified during a clinical trial that could lead to a violation of the study protocol if not addressed, but has not yet actually occurred. These potential PD records can be automatically generated by running an R script via Script-generated Reports. The mail history of script-generated potential PD records includes details such as when notifications were sent, to whom, and the status of each message, ensuring transparency and traceability in correspondence.

To analyze the mail history of a script-generated potential PD

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, select Protocol Deviation > Potential PDs Generated by Script.

    Accessing script-generated potential PDs
    Figure 3. Accessing script-generated potential PDs

  3. On the page that opens, select a tab depending on the one that contains the required potential PD records.

    Tip

    In Script-generated Reports, you can create multiple potential PD reports using R scripts. Each time a script is run, the system generates a new tab named after the report, which displays the corresponding potential PD records.

  4. In the table listing script-generated potential PD records, from the workspace toolbar, select Mail History mail_history_icon.png.

    Accessing mail history of script-generated potential PD
    Figure 4. Accessing mail history of script-generated potential PD

  5. In the Mail History dialog that opens, select Download download_icon.png to export a particular mail in a PDF file to your computer or select Preview eye_icon_gray.png to view this mail in the browser.

Once previewed, you can select CLOSE to go back to the script-generated potential PD and proceed with configurations as needed..

Export script-generated potential PD record list

In CTMS, you can export the script-generated potential protocol deviation (PD) records from the system into a structured file. This makes it easier to review, share, or archive records outside the system while maintaining data accuracy and consistency.

To export the script-generated potential PD record list

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, select Protocol Deviation > Potential PDs Generated by Script.

    Accessing script-generated potential PDs
    Figure 3. Accessing script-generated potential PDs

  3. On the page that opens, select a tab depending on the one that contains the required potential PD records.

    Tip

    In Script-generated Reports, you can create multiple potential PD reports using R scripts. Each time a script is run, the system generates a new tab named after the report, which displays the corresponding potential PD records.

  4. In the table listing script-generated potential PD records, from the workspace toolbar, select Export import_icon.png.

    Exporting script-generated potential PD
    Figure 4. Exporting script-generated potential PD

  5. The downloads widget appears showing the export progress. Select the widget to access exported files.

    Downloads widget showing potential PD records being exported
    Figure 5. Downloads widget showing potential PD records being exported

  6. In the My Downloads dialog that appears, in the Download is Ready tab, select download_icon.png next to the required exported file.

    Downloading exported potential PD records
    Figure 6. Downloading exported potential PD records

Once selected, the script-generated potential PD records are downloaded as an XLSX file to your computer.

In this section:

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 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.

An electronic version of a trial master file (TMF) is a type of content management system for a clinical trial used to organize and store files required for compliance with government regulatory authorities like the FDA, EMA, or others.

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

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion criteria, failing to perform a required lab test, and so on.