Changes between Version 2 and Version 3 of TOTAL Study

Timestamp:

10/24/13 12:21:53 (11 years ago)

Author:

Nick Holden

Comment:

--

TOTAL Study

@@ -15 +15 @@
 New study: TOTAL
 
-* Standard Timeline
-  * Assent / recruitment
-  * Randomisation ( 0 days)
+* Standard Timeline (ORDER BY DATE)
+  * Assent / randomise
+  * Randomisation ( 0 days) - probably don't need this
   * Consent (1 day)
   * Follow up visit (30 days)
@@ -25 +25 @@
 New custom data group for TOTAL enrolments: 
 * TOTAL
-  * Version of consent used
-  * Randomisation arm
-  * Study ID
+  * Version of consent used (e.g "1.3"
+  * Randomisation arm (two arms)
+  * Study ID (six digit number, default is "941"?)
 
 New custom data group for all enrolments: 
 * Serious Adverse Event
   * Category
+  * Date of SAE
   * Description
+  * Date of report to R&D
+  * Date reported to sponsor
+ (delete the location and assessment fields)
 
-Maybe we could adjust the SAE reporting data so that it is possible to print from CiviCRM the necessary SAE report form to submit to NRES?
+Maybe we could adjust the SAE reporting data so that it is possible to print from CiviCRM the necessary SAE report form to submit to NRES? Each study reports to different bodies (sponsor, etc). Complicated.
 
 See here: http://www.nres.nhs.uk/applications/after-ethical-review/safetyreports/safety-reports-for-all-other-research/
 
+TO DO:
+
+Minor changes on TEST
+Email Emma with link to test system
+Write a Work Instruction