Investigator documents and resources

TOPIC 2 Protocol

A link to the Protocol can be found here.

A link to the Trial Summary can be found here.

TOPIC 2 PIS, GP Letters & Consent Forms

Link to the current Patient Information Sheet.

Link to the current Informed Consent Form.

Link to the current GP Letter.

Link to the current Audio-recording Discussions and Interviews PCF.

Link to the current Healthcare Professional Information Study and Audio-recording Consent Form.

Link to the current Invitation Letter.

Link to the current Audio-recording Discussions and Interviews PIS.

Link to the current General Version Control List.

Link to the current Patient Completed Booklet: 3, 6 and 12 month cover letter.

 

 

Please click the links below to download and print CRFs for TOPIC 2.

TOPIC 2 CRFs and Forms

A link to the current CRF Version Control List can be found here.

A link to the current Consent and Randomisation Form can be found here.

A link to the current Baseline Medical Data Form can be found here.

A link to the current Intervention Form can be found here.

A link to the current Operation Details Form can be found here.

A link to the current Acute Day 0 Post-recovery Form can be found here.

A link to the current Acute Phase Up to Day 3 Form can be found here.

A link to the current Acute Phase Day 4 to Discharge Form can be found here.

A link to the current Trial Exit/Change of Status Form can be found here.

A link to the current Serious Adverse Event (SAE) Reporting Form can be found here.

A link to the current Healthcare Contacts Form can be found here.

A link to the current Patient Completed Booklet: 3, 6 and 12 month cover letter can be found here.

A link to the current Thoracic Epidural Blockade and Paravertebral Blockade Guidelines can be found here.

The Online Database Guidelines for Site Users can be found here.

The TOPIC2 CRF Completion Guidelines can be found here.

REC - A link to the Acknowledgement of Documents following Favourable Opinion With Conditions can be found here.

REC - A link to the Favourable Opinion With Conditions can be found here.

REC - A link to the Provisional Opinion can be found here.

HRA - A link to the Letter of HRA Approval can be found here.