Study Documents
The current version of the Protocol is version 5.1, 7th December 2021.
Below is a table with a list of all the Current Trial Documents [1,289KB] :
| Document title | Version | Date |
| UKITPR Study Protocol | 4.1 | 07-Dec-21 |
| UKITPR Participant information sheet (PIS) | 5.1 | 07-Dec-21 |
| UKITPR Pregnancy Participant information sheet (PIS) | 2.1 | 07-Dec-21 |
| UKITPR Study Informed Consent Agreement | 6.1 | 07-Dec-21 |
| UKITPR Pregnancy Study Informed Consent Agreement | 1.0 | 16-May-18 |
| UKITPR Invitation letter to participant and remote consenting | 1.0 | 06-Jul-20 |
| UKITPR Invitation letter to participant and remote consenting - Pregnancy registry | 1.0 | 06-Jul-20 |
| GP/consultant information sheets or letters [UKITPR GP letter template] | 1.2 | 16-May-18 |
Other miscellaneous documents to support the study delivery (can be downloaded here):
| Document title | Version | Date |
| Other [Centre Delegation Log] | N/A | 16-May-18 |
| 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] | 4.0 | 07-Dec-21 |
| Other [Follow up data collection sheet] | 4.0 | 07-Dec-21 |
| Other [Pregnancy Registration Sheet] | 2.0 | 07-Dec-21 |
| Other [Pregnancy status and outcome sheet] | 2.0 | 07-Dec-21 |
All previous versions of the study documents have been superseded and should not be used.
Previous study documents [23,279KB] and relevant approvals are also available for sites that require them for their trial master files.