Create Amendment

 

An amendment is a request by the researcher to make a change to a previously approved protocol. This can be simple administrative information, such as updating contact information on consent materials, or it can be something related to the study design, such as addition of data collection procedures or a subject cohort. Only protocols in active or exempt status can be amended.

 

Table 305 Protocol Document, Protocol Actions Page, Request an Action Section, Create Amendment Action – Action Attributes

  Action attributes

Description

Who can perform action

Principal Investigator, Co-PI Student/Fellow/Resident, Study Manager/Correspondent, and Aggregator can initiate this action.

Protocol state prior to action

Prior to the action being performed, the protocol must be in the following Status:

 

  • Active – Open to Enrollment
  • Active – Closed to Enrollment
  • Active – Data Analysis Only
  • Exempt

The Submission Status can be in any state.

 

 

Protocol state after action

After the action is performed

 

  • The protocol's status will not change; however, you will be moved to the Amendment document, which will have the same protocol number followed by an A00X suffix.

  • The Amendment will have a Status of "Amendment in Progress," and a blank Submission Status.

 

 

Figure 686 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Create Amendment Layout

 

Table 306 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Create Amendment Field Descriptions

Field

Description

Summary

Enter a summary of the reason(s) for the amendment, being as specific as possible. Click within the text box to type or paste text. Click the add note  icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document.

Amend

Select one or more portions of the Protocol document, and/or Questionnaires if they are active for this study, that you intend to amend. A check mark appears within the check box to indicate the item is selected. Note that you must select the Add/Modify Attachments and Notes box in order to upload any revised documents. If there is already an outstanding amendment for the protocol, any portions being updated by it will not be available for a new amendment.

Click the create button to initiate a new Amendment. You will then be able to make changes to the portions selected under Amend.


The Questionnaire Tab will open, and the Amendment Questionnaire will be listed under Submission Questionnaires.  Questionnaires that have not been selected for editing, or that do not apply to this study, will be listed under Read-Only Questionnaires.

 

The system will create an Amendment document with the number of the protocol followed by a suffix of A001 for the first amendment, A002 for the second amendment, and so on. Once the Amendment is approved, the changes are merged with the original protocol, and the separate amendment document with the suffix of A00* ceases to exist.

It is possible to have more than one amendment outstanding at the same time, but to avoid conflicting information KC does not allow two amendments to update the same section of the protocol at the same time. Once any amendment to a protocol is approved, study information in all outstanding amendments to the same protocol will be updated automatically by the system to reflect the changes to the original protocol made by the approved amendment.