Sealed Envelope | Making changes to the specification

Flowchart for change request process

Once a Red Pill or randomisation system is in production, changes to the forms or other aspects of the system can only be done through a documented change control process. To initiate this process please download and complete a Change Request spreadsheet [Excel file].

The Change Request Log will require you to complete the following information:

Change #: Sequential change number 1, 2, 3, …
Visit: Name of visit, e.g. Baseline
Form: Name of form, e.g. ECG results
Item / Question: The question to be added or changed, eg. 1. ECG - Has a baseline ECG been taken?
Change type: One of:

New form
New field
Change field
Other change

New or revised forms and fields might be required due to a change in the protocol or a mistake in the original specification. Other changes include changes to validation rules or user permissions etc.

If new field, please record response required: When adding new fields, please list what type of response is expected. Please choose from:

Single line text
Paragraph text - a text box allowing long text entries
Encrypted text - a text box whose value will be stored in an encrypted format
Number
Date
Yes/No
Category - please list all categories eg, Mild; Moderate; Severe
Clock time - the time of day in 24hr clock format (e.g. 13:15)
Elapsed time - a duration in hours and minutes (e.g. 30:50)
Explanation - explanatory text (e.g. The following questions are about your health)

Change description: The actual change that is required in the eCRF. e.g. The drop down menu is missing a category and should be updated to include new option in drop down menu

Once you have completed the form, please send it to Sealed Envelope for review. Sealed Envelope will review your list of changes and provide you with an estimate of how long it will take to configure these changes and provide you with a cost estimate to fulfil your request.