Study Documents
The current version of the Protocol is version 5.2, 12th November 2024.
Below is a table with a list of all the Current Trial Documents [1,694KB] :
| Document title | Version | Date |
| UKITPR Study Protocol | 5.2 | 12-Nov-24 |
| 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] | 3.1 | 01-Aug-24 |
| 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All previous versions of the study documents have been superseded and should not be used.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 [27,296KB] and relevant approvals are also available for sites that require them for their trial master files.