What are Messages?
Messages capture detailed information that may be of interest to users. Some examples of Messages are validation messages that are returned when uploading a study to ClinicalTrials.gov, or user comments on studies, forms, or tasks. Once the data is captured, it can be displayed in various parts of the application.
How do I access Messages?
Messages can be accessed directly on the top-navigation under Browse, and then Messages.
Messages can also be accessed directly from a study on the left-navigation by clicking on Messages. These messages will be filtered for the study.
What Information is captured on a Message?
Text - This is the content of the message.
Unique Study ID - This field identifies the study to which the comment belongs.
Entity Type - The Entity Type is the source of the message, such as a form or a study. The current set of entities can be found below under: What Entity Types can have Messages?
Type - The Type indicates the type of messages that are captured, such as user comments or a data change. The current set of message types can be found below under: What types of Messages are captured?
Sub Type - The Sub Type defines the type more specifically. For example, for Study Action message, the Sub Type indicates if the comment was for an assessment change or the creation of a submission record. The current set of message sub types can be found below under: What are message Sub Types?
Process Cycle - The Process Cycle captures the workflow process cycle, such as Initial, Edit, Approval. The current set of Process Cycles can be found below under: What is a Process Cycle?
Created By - This is the User Name of the user associated with a particular message.
Created Date - This the date and time when the message was created.
What Entity Types can have Messages?
An Entity Type is the source of a message. There are many entities that may be associated to a message, and the list may expand. The current set of entities are as follows:
Study related entities
Study
Attachment
Study Assessment
Compliance Tracker
ClinicalTrials.gov related entities
Protocol Registration Form
Results Registration Form (RRF)
Delayed Results Form
gov Submission
EudraCT related entities
Clinical Trial Application Form
EU CTA Submission
EudraCT Results Form (ERF)
EudraCT Results Submission
Other entities
Task
Import Record
ST Submission
What types of Messages are captured?
The message Type indicates the type of message that is captured. There are many types of messages that may captured, and the list may expand. The current Types of messages are as follows:
User Comments - When a user makes a comment on form, study, or task, the comment is captured as a message. In addition to the actual comment, the entity (form, study, task) on which the comment was made is captured, along with
Study Health Monitor - When the Study Health Monitor runs, it captures the results as a message. These messages are displayed on the Study Overview. -
Submission Upload - When PharmaCM submits study information to an external site, such as ClinicalTrials.gov, the response from that site is captured as a message. In the case of ClinicalTrials.gov, the message displays the screen that is presented after the submission is attempted. It may include the validation messages if the study is accepted, or information on the error if the study is not accepted.
Study Action - Study Actions capture comments from certain activities performed on a study. For example, if a study is assessed by importing a ClinicalTrials.gov XML file, the assessment will include ‘Disclose Comments’ stating that the Assessment Change was due to the import.
Data Change - An administrator can select to monitor data changes on certain study and PRF fields. When one of these monitored fields change, a message is captured upon check-in that describes the field, the original value, and the changed value. These messages are included on the Study Data Change email subscription.
gov QA Comment - This is not currently used
System Message - This is not currently used
Task Action - This is not currently used
What are message Sub Types?
The message Sub Type further refines the type of message that is captured. There are many sub types of messages that may captured, and the list may expand. The current Sub Types of messages are as follows:
Error - Errors indicate that something was not completed as expected. When the error sub-type is used in conjunction with a Submission Upload, it indicates that the upload may have failed.
Warning - This is not currently used
Information - The message is informational in nature.
Review Comment - The message was added as a reviewer comment on an entity.
Approval/Rejection Comment - The message was added as an approval or rejection comment (on the task).
Assessment Monitor - The message is associated with the Assessment Monitor.
Compliance Monitor - The message is associated with the Compliance Monitor.
Dates Monitor - The message is associated with the Dates Monitor.
Roles Monitor - The message is associated with the Roles Monitor.
Workflow Monitor - The message is associated with the Workflow Monitor.
Study Creation - This message is associated
Study Mode Change - This is not currently used
Task Reassign - A task was re-assigned from one user to another in the task scheduler.
Assessment Change - A ‘Disclose Comment’ was added to the assessment
Create Submission - A comment was added on the Create Submission screen
Esign Comment - A comment was added in the eSignature box
Registry Response - This message captures the response from a registry, such as ClinicalTrials.gov.
System Message - Messages from the PharmaCM system.
What is a Process Cycle?
Process Cycles indicate the step or group of related steps in a workflow.
Initial – the workflow has started, but needs more information to process, such as assigning roles or uploading an attachment
Edit – the workflow is in the edit stage; one or more edit tasks are assigned
Review – the workflow is in the review stage; one or more review tasks are assigned
Approve – the workflow is in the approve stage; one or more approval tasks are assigned
Upload – the workflow is in the upload stage; the upload task is assigned
Sent – the insurance