Study Documents

The current version of the Protocol is version 5.0, 1st August 2023.

Below is a table with a list of all the Current Trial Documents [1,699KB] :

Document title	Version	Date
UKITPR Study Protocol	5.0	01-Aug-23
UKITPR Participant information sheet (PIS)	6.0	01-Aug-23
UKITPR Pregnancy Participant information sheet (PIS)	3.0	01-Aug-23
UKITPR Study Informed Consent Agreement	7.0	01-Aug-23
UKITPR Pregnancy Study Informed Consent Agreement	2.0	01-Aug-23
UKITPR Invitation letter to participant and remote consenting	2.0	01-Aug-23
UKITPR Invitation letter to participant and remote consenting - Pregnancy registry	2.0	01-Aug-23
GP/consultant information sheets or letters [UKITPR GP letter template]	1.2	16-May-18

 

Other miscellaneous documents to support the study delivery:

Document title	Version	Date
Other [Centre Delegation Log]	2.0	01-Aug-23
Other [UKITP Registry Data Entry Guide on REDCap Database]	4.0	04-Nov-21
Other [UKITP Pregnancy Registry - REDCap Database - Data Entry Guide]	1.1	25-Feb-22
Other [GP proforma]	1.2	16-May-18
Other [Initial data collection sheet]	5.0	01-Aug-23
Other [Follow up data collection sheet]	5.0	01-Aug-23
Other [Pregnancy Registration Sheet]	3.0	01-Aug-23
Other [Pregnancy status and outcome sheet]	3.0	01-Aug-23
Other [Secondary ITP Initial Data Collection Sheet ]	2.0	01-Aug-23
Other [Secondary ITP Follow Up Data Collection Sheet]	2.0	01-Aug-23

All previous versions of the study documents have been superseded and should not be used. 

Previous study documents [25,939KB] and relevant approvals are also available for sites that require them for their trial master files.