Medical History

*The timeline requirements for this form are as follows:
Assessment Time Frame: Screening through end of study.
Submission Time Frame: Within 5 days of initial collection, and ongoing as conditions are updated.

Medications are logged on a Common Form, which is available at the bottom of the subject’s page in EDC. Click +New to log a new instance. Each reportable SAE medical history condition should be entered as a new instance. The maximum number of new events which can be added is 100.

*Medical History or Conditions present prior to conditioning that are relevant to an SAE occurrence should be recorded on this form. The reported Medical History should then be linked to the corresponding SAE form. Please enter SAE related medical condition.

Condition:
Report the medical history condition (up to 200 characters)

Start Date:
Enter the start date of the medical history condition. This field allows for partial or unknown data elements. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.

End Date:
Enter the date of the last dose of this concomitant medication or the date before the dose changes. This field allows for partial or unknown data elements. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.

Medical condition ongoing:
If medical history condition is ongoing, select this option. If selected, the preceding field (End Date) will disappear. Please ensure this field is updated and that an end date is added, once medical history condition ends.

Adverse Event form linking:
If the medical history instance is associated with an Adverse Event, the appropriate Adverse Event form can be linked directly to the Medical History form.

To add a link to an AE form, you must first have entered the AE form to report the event. Next, on the Medical History form click +Add Link under the Adverse Event heading. In the pop-up window, select the Adverse Event to link by clicking on the checkbox to the left of the Reference # then click Save.

Concomitant Medications form linking:
If the medical history instance is associated with a Concomitant Medication, the appropriate Concomitant Medication form can be linked directly to the Medical History form.

To add a link to a Concomitant Medications form, you must first have entered the Concomitant Medications form to report the medication. Next, on the Medical History form click +Add Link under the Concomitant Medications heading. In the pop-up window, select the Concomitant Medications to link by clicking on the checkbox to the left of the Reference # then click Save.

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