Investigator documents and resources

The following resources contain information for use by collaborators involved in the Predict and Prevent Trial. They are the property of the University of Birmingham and do not constitute any form of advice to participants.

Please do not hesitate to contact the Predict and Prevent trial team should you have any queries:

Email: predictandprevent@trials.bham.ac.uk 

Telephone: 0121 415 9120

Fax: 0121 415 9135

Please see the links below to access Predict and Prevent documentation.

If you require patient completed booklets please contact the trial office.

Protocol and other REC-approved documentation

Predict and Prevent Protocol

A link to the Protocol can be found here

Predict and Prevent PIS, GP Letters & Consent Forms

Link to current Consent Video- Contact the trial team directly

Link to the current Patient Information Sheet

Link to the current Informed Consent Form

Link to the current GP Letter

Link to the current Predict and Prevent Healthcare Professional Information Sheet and consent 

Link to the current Predict and Prevent Qualitative Patient Information Sheet

Link to the current  Predict and Prevent Qualitative Consent Form 

Link to current recruitment poster Recruitment poster for display

Case Report Forms (CRFs)

Please click the links below to download and print CRFs for Predict and Prevent.

Predict and Prevent 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 Home Visit Form can be found here

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

A link to the current 3-month Telephone Follow-up Form can be found here

A link to the current 6-month Clinic Follow-up Form can be found here

A link to the current 9-month Telephone Follow-up Form can be found here

A link to the current 12-month Clinic Follow-up Form can be found here

A link to the current Baseline Patient Completed Patient Booklet can be found here

A link to the current 3-month Nurse Completed Patient Booklet can be found here

A link to the current 6-month Patient Completed Patient Booklet can be found here

A link to the current 9-month Nurse Completed Patient Booklet can be found here

A link to the current 12-month Patient Completed Patient Booklet can be found here

A link to the current Concomitant Medication Form can be found here 

A link to the current Serious Adverse Event Form can be found here

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

Guidelines and supporting documents

The Online Database Guidelines for Site Users can be found here

Initial REC & HRA Approvals

REC - A link to the Favourable Opinion- further information required can be found here

REC - A link to the Favourable Opinion with conditions can be found here

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

Trial Amendments

Substantial Amendments

Substantial Amendment 01

Substantial Amendment 01 -HRA Approval 

Substantial Amendment 01 -REC FAvourable Opinion

Cover letter to REC - Substantial Amendment 01

Signed Notification of Substantial Amendment 01

Protocol v4.0

Patient Information Sheet v4.0

Substantial Amendment 02

Substantial Amendment 02 -HRA Approval 

Substantial Amendment 02 -REC Favourable Opinion

Cover Letter to REC - Substantial Amendment 02

Locked Substantial Amendment Tool 02

Protocol v5.0

Predict and Prevent AECOPD Qualitative Patient Consent Form V1.0 

Predict and Prevent AECOPD Qualitative Patient Information Sheet V1.0

Substantial Amendment 03

Substantial Amendment 03- HRA Approval

Substantial Amendment 03- REC Favourable Opinion 

Cover letter to the REC- Substantial Amendment 03

Locked Substantial Amendment Tool 03

Protocol v6.0 

Predict and Prevent AECOPD Patient Information Sheet V5.0 Vd 22-Feb-2021

 Substantial amendment 04

Substantial Amendment 04- HRA Approval 

Substantial Amendment 04- REC Favourable Opinion

Locked Substantial Amendment Tool 04

Protocol v7.0

Patient Information Sheet v6.0

Informed Consent Form v4.0

GP Letter v3.0

Recruitment poster v1.0

PredictPrevent Healthcare Professional Information Study and Audio-recording Consent Form v2.0a

Substantial amendment 05

Substantial Amendment 05- HRA Approval 

Substantial Amendment 05- REC Favourable Opinion

Locked Substantial Amendment Tool 05

Protocol v8.0

Substantial amendment 06

Substantial Amendment 06- HRA Approval 

Substantial Amendment 06- REC Favourable Opinion

Locked Substantial Amendment Tool 06

Protocol v9.0

PIS v7.0

GP letter v4.0