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Master ICFs

Master ICFs are the general Informed Consent Form documents designed for the study according to the regulatory requirements and protocol specifications. These are the master documents that serve as the basis for the site ICFs.

In CTMS, with master ICF listing, you can manage the relations of master ICFs to site ones, access their main details, such as protocol version or else, as well as maintain versioning. The Master ICFs list displays all the existing master ICF listing records of the study with their respective details, as explained in the following table.

Master ICF list
Figure 1. Master ICF list

Important

You can configure master ICF listing and add more custom columns if needed. The following table only lists the preset general columns of Master ICFs.

Element

Details

ID

Represents the unique identifier of the master ICF listing record autogenerated upon its creation by the CTMS system.

ICF Name

Represents the name of the master ICF entered manually upon creation or editing by the CTMS user.

ICF Version

Represents the current version of the master ICF.

Consent Method

Represents how the subjects of the study can give their consent for this ICF.

The values can be customized to suit your study business needs, for instance, they can be Electronically or On paper, or you can add Verbally if it is acceptable.

Language

Represents the language of the master ICF.

Local/Central IRB

Represents whether the master ICF is reviewed and approved by the central Institutional Review Board (IRB) for the study or the local IRB in the region where this ICF applies.

Submission Date

Represents the date when the master ICF has been submitted for review to the IRB.

ICF Approved Date

Represents the date when the IRB has approved the master ICF.

Expiration Date

Represents the date when the master ICF becomes expired.

Description

Represents auxiliary details provided upon creation or editing of the master ICF listing record in CTMS.

In the following sections, you can learn how to manage the master ICF listing records in CTMS:

Configure master ICF listing

Master ICFs are the general Informed Consent Form documents designed for the study according to the regulatory requirements and protocol specifications. These are the master documents that serve as the basis for the site ICFs.

When managing master ICF records in CTMS, you can configure the data elements to be included in the master ICF listing record to provide exhaustive details for efficient management.

To configure the master ICF listing

  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 management page that opens, from the left pane, select ICF > ICF Listing.

    Accessing ICF listing
    Figure 3. Accessing ICF listing

  3. On the page that opens, select the Master ICFs tab. Then from the workspace toolbar, select Setting Gear_icon_gray.png.

    Accessing master ICF listing setting
    Figure 4. Accessing master ICF listing setting

  4. In the dialog that appears, under the Settings tab, you can view all the currently existing data elements of the master ICF listing. To add a new data element, from the workspace toolbar, select New Item add_new_icon.png.

    Selecting to add master ICF listing data element
    Figure 5. Selecting to add master ICF listing data element

  5. At the bottom of the list, in the new row added, enter the details for the master ICF listing data element as explained in the following table.

    Adding new data element to master ICF listing
    Figure 6. Adding new data element to master ICF listing

    Element

    Details

    Name

    Enter the name of the new data element you want to add to the master ICF listing.

    Data Type

    Enter the data type of the element, such as:

    • Text: requires the user to enter any text as value.

    • Numeric: requires the user to enter only a numeric value.

    • Date: requires the user to select the date as value.

    • Dropdown List: requires the user to select one of the preset values. For this data type, you need to configure items.

    • Dropdown List and Text: gives the user options to enter free text, select one of the predefined values, or select and edit the predefined values.

    Items

    If the selected data type includes a dropdown list, then enter the values to be available for selection. Use commas to separate multiple dropdown values.

    For example, for the Consent Method field, you can enter values as follows: Electronically, On paper, Verbally.

    Is Required

    Select Yes or No to indicate whether the data element is a mandatory or optional field for completion when creating or editing the master ICF.

    Is a Preset Attribute

    Represents if a data element in the ICF is a system defined (predefined) or created by a user.

    Modified By

    Represents the user who last modified the field setting.

    Modified Time

    Represents the time when the field setting was last modified.

    Save

    Select Save_icon_green_tick.png to add the field to ICF.

    Close

    Select x_icon.png to discard the changes without saving.

  6. Once saved, the new field is added. You can now perform the following actions to the custom or some of the preset fields:

    • Edit pencil_icon_gray.png: select this option next to the data element to update its settings as explained in the preceding table.

    • Delete Delete_icon_gray.png: select this option next to the data element to delete it from the master ICF listing. To confirm the action, in the dialog that appears, enter the reason for deletion and select SAVE.

    • Move Move_icon.png: select this option next to the data element and drag it to move the element to a different position.

    • Operation History: for analysis purposes, access the log of all actions on the master ICF listing configurations. Recording operation history ensures keeping track of all customizations and being responsible for them.

    Managing custom and preset data elements of master ICF listing
    Figure 7. Managing custom and preset data elements of master ICF listing

You have configured the data elements of the master ICF listing.

Create new master ICF listing record

Master ICFs are the general Informed Consent Form documents designed for the study according to the regulatory requirements and protocol specifications. These are the master documents that serve as the basis for the site ICFs.

In CTMS, to manage the master ICFs and their relations to site ones, as well as maintain versioning, you need to add all the master ICFs as listing records to the system.

To create a new master ICF listing 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 management page that opens, from the left pane, select ICF > ICF Listing.

    Accessing ICF listing
    Figure 3. Accessing ICF listing

  3. On the page that opens, select the Master ICFs tab. Then from the workspace toolbar, select New Item add_new_icon.png.

    Selecting to add new master ICF listing record
    Figure 4. Selecting to add new master ICF listing record

  4. In the New dialog that appears, add the master ICF details as explained in the following table.

    Important

    The fields in this dialog may vary based on the master ICF listing configurations.

    Adding master ICF listing record details
    Figure 5. Adding master ICF listing record details

    Tip

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

    Element

    Details

    ICF Name*

    Enter the name of the master ICF for which you are creating the listing record.

    ICF Version*

    Enter the version of the master ICF for which you are creating the listing record.

    Language

    Select the language of the master ICF.

    Local/Central IRB

    Select whether the master ICF is reviewed and approved by the central Institutional Review Board (IRB) for the study or the local IRB in the region where this ICF applies.

    Submission Date

    Select the date when the master ICF has been submitted for review to the IRB.

    ICF Approved Date

    Select the date when the specified master ICF version has been approved by IRB.

    Expiration Date

    Select the date, if any, when the established ICF version expires and becomes outdated.

    Description

    Enter additional details about the established master ICF version for other users' acknowledgment.

    SAVE

    Select save_button.png to implement the changes.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes without saving.

Once saved, the master ICF listing record is added. The ID number is autogenerated by the system for this record for tracking purposes.

Edit master ICF listing record

ICF tracking log is a functionality used to track the distribution, collection, and status of Informed Consent Forms (ICFs) from participants in the trial. It is a management tool that ensures proper documentation and completion of all steps related to informed consent throughout the trial process.

In CTMS, to manage the master ICFs and their relations to site ones, as well as maintain versioning, you need to add all the master ICFs as listing records to the system. Once added, the master ICF listing record can be edited to adjust it to the changing study requirements.

Tip

You cannot edit the inactive master ICF listing record.

To edit a master ICF listing 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 management page that opens, from the left pane, select ICF > ICF Listing.

    Accessing ICF listing
    Figure 3. Accessing ICF listing

  3. On the page that opens, select the Master ICFs tab. Then in the table that appears, locate the record whose details you need to update and from the Action(s) column next to it, select Edit pencil_icon_gray.png.

    Selecting to edit master ICF listing record
    Figure 4. Selecting to edit master ICF listing record

    Tip

    If your master ICF is referenced in the site ICF that already has a tracking log record created, the notification appears that changing master ICF details can affect the tracking log data. Select CONFIRM to acknowledge the warning and proceed to editing.

    Receiving notification on potential data change
    Figure 5. Receiving notification on potential data change

  4. In the Edit dialog that appears, update the master ICF listing record details as needed. These details are identical to the ones explained in the table of the Create new master ICF listing record section.

    Important

    The ID field is read-only as this value is autogenerated by the system for the master ICF listing record upon creation for tracking purposes

    The fields in this dialog may vary based on the master ICF listing configurations.

    Editing master ICF listing record details
    Figure 6. Editing master ICF listing record details

  5. Select save_button.png to implement the changes.

Once saved, the master ICF listing record details are updated.

Activate/Inactivate master ICF listing record

Master ICFs are the general Informed Consent Form documents designed for the study according to the regulatory requirements and protocol specifications. These are the master documents that serve as the basis for the site ICFs.

The master ICF listing record must be activated to be able to reference it when adding site ICFs. If you have the master ICF listing record that is not relevant to the study, you can inactivate it. Thus, when creating tracking log records, only the active master ICFs will be available for selection.

To activate or inactivate a master ICF listing 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 management page that opens, from the left pane, select ICF > ICF Listing.

    Accessing ICF listing
    Figure 3. Accessing ICF listing

  3. On the page that opens, select the Master ICFs tab and in the table that appears, locate the record of your interest. Then next to your record, from the Action(s) column, select Activate activate_icon.png or Inactivate inactivate_icon.png.

    Selecting to activate or inactivate master ICF listing record
    Figure 4. Selecting to activate or inactivate master ICF listing record

  4. In the Reason dialog that appears, provide the arguments to justify your action. Then select save_button.png.

    Providing reason for inactivating master ICF listing record
    Figure 5. Providing reason for inactivating master ICF listing record

Once the reason is saved, the master ICF listing record becomes active or inactive based on your performed action.

Review master ICF listing record reference items

Master ICFs are the general Informed Consent Form documents designed for the study according to the regulatory requirements and protocol specifications. These are the master documents that serve as the basis for the site ICFs.

In CTMS, you can trace the connection between the master ICF and all the site ICFs related to it by reviewing reference items for the master ICF.

Important

To be able to reference master ICFs in site ICFs, you need to configure the Reference from Master ICF data type elements in your site ICF listing settings. Then you can add related master ICFs when creating new or editing the existing site ICFs.

To review the master ICF listing record reference items

  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 management page that opens, from the left pane, select ICF > ICF Listing.

    Accessing ICF listing
    Figure 3. Accessing ICF listing

  3. On the page that opens, select the Master ICFs tab and in the table that appears, locate the record of your interest. Then from the Action(s) column next to the record, select More more_icon.png > Reference Item reference_item_icon.png.

    Selecting to view references for master ICF listing record
    Figure 4. Selecting to view references for master ICF listing record

  4. In the Reference Item dialog that opens, review all the site ICFs related to this master ICF version.

    Reviewing referenced items for master ICF listing record
    Figure 5. Reviewing referenced items for master ICF listing record

You have reviewed the list of the site ICFs related to a certain master ICF. You can now select close_icon_red.png to return to the Master ICFs list.

Analyze master ICF listing record operation history

Master ICFs are the general Informed Consent Form documents designed for the study according to the regulatory requirements and protocol specifications. These are the master documents that serve as the basis for the site ICFs.

In the course of a clinical trial, various modifications can be made to the master ICF listing record, and it is vital to keep record of such changes for compliance and traceability reasons. The operation history provides an exhaustive, structured log of events, helping you trace what they were, who performed them, and when.

To analyze the master ICF listing record operation history

  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 management page that opens, from the left pane, select ICF > ICF Listing.

    Accessing ICF listing
    Figure 3. Accessing ICF listing

  3. On the page that opens, select the Master ICFs tab and in the table that appears, locate the record of your interest. Then next to your record, select More more_icon.png > Operation History history_icon.png.

    Accessing master ICF listing record operation history
    Figure 4. Accessing master ICF listing record operation history

  4. In the Operation History dialog that opens, analyze the complete history of actions performed to the master ICF listing record from its creation and up to date.

    Analyzing operation history for master ICF listing record
    Figure 5. Analyzing operation history for master ICF listing record

You have analyzed the operation history for the master ICF listing record. You can now select OK to close the dialog and return to the Master ICFs list.

Delete master ICF listing record

Master ICFs are the general Informed Consent Form documents designed for the study according to the regulatory requirements and protocol specifications. These are the master documents that serve as the basis for the site ICFs.

Since throughout the study the protocol and the ICF requirements can change due to evolving circumstances, you need to maintain the master ICF listing records up-to-date. If some record is no longer relevant to your study, you can remove it from the list to avoid records cluttering.

Important

To delete the master ICF listing record, it must be inactivated.

To delete a master ICF listing 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 management page that opens, from the left pane, select ICF > ICF Listing.

    Accessing ICF listing
    Figure 3. Accessing ICF listing

  3. On the page that opens, select the Master ICFs tab and in the table that appears, locate the record of your interest. Then from the Action(s) column next to the record, select More more_icon.png > Delete trash_can_icon.png.

    Deleting master ICF listing record
    Figure 4. Deleting master ICF listing record

  4. In the Reason dialog that appears, provide the arguments to justify your action. Then select save_button.png.

    Providing reason for master ICF listing record deletion
    Figure 5. Providing reason for master ICF listing record deletion

Once confirmed, the master ICF listing record is deleted.

In this section:

A document that provides essential information about a clinical trial to potential participants to ensure their complete understanding of the research nature, the risks and potential benefits involved, and their rights as participants.

Before enrolling in a clinical trial, participants must read and understand the information in the ICF, and signing the ICF indicates their willingness to participate, understanding that they have been fully informed about the study.

In a clinical trial, a document that describes the objectives, design, methodology, statistical considerations, and aspects related to the organization of a study.

A participant who is enrolled in a clinical trial and assigned to the site.