Trial documentation

 

Please follow the links below to obtain all of the information required by investigators on the MEDAL Study.

 

Study Documentation:

Protocol v3.0 - 12th August 2013

PIS V2.0 - 11th July 2012

MEDAL Contact List - Cover sheet v1.2 30-01-2012

Patient Letter v1.0 - 26th September 2012

MEDAL_GPletter_v1.2_16-12-2011

MRI Information Sheet_v1.2_09-01-2012

Participant Registration Form v2.0 05-09-2012 (APPENDIX C in Protocol)

Form 02(a) Pelvic Pain Assessment Questionaire V2.1 27-11-2012

Form 02(b) Pelvic Pain Assessment Questionaire (Patient re-entry) V2.1 27-11-2012

Form 05(a) Diagnostic Consent v3.0 - 12th August 2013

Form 05(b) Data Consent v3.0 - 12th August 2013

Form 09 - Medal six month follow-up questionaire v2.1 27-11-2012

 

 

 

MRI Letters where MRI Report sent:

Release of MRI Patient Letter (V 1 0 - 9th April 2013) - no pathology

Release of MRI Patient Letter (V1 0 - 9th April 2013) - pathology

Release of MRI Report GP Letter (V1 0 - 17th July 2013) - no pathology

Release of MRI Report GP Letter (V1 0 - 17th July 2013) - pathology

 

 

MRI Letters without MRI Report:

MRI findings GP Letter (V1 0 - 6th November 2013) - no pathology

MRI findings GP Letter (V1 0 - 6th November 2013) - pathology

 

 

Data Collection Forms:

Form 01 - MEDAL - Patient Screening Log v0.6 - 21st Sept 2012

Form 03 - Medal Clinical Examination v1.7 26-11-2012

Form 04 - Medal Study Ultrasound Report v1.4 08-11-2012

Form 06 - Management Working Diagnosis and Diagnostic Plan v1 7 05-07-2012

Form 07(a)(b) - Medal Study MRI Report v1.7 04-03-2013

Form 08 - Medal Intraop Assessment (Laparoscopy) v2.3 23-10-2012

Serious Adverse Event Form - Protocol V2.0 - 5th September 2012 (Appendix E in Protocol 2.0 05-09-2012)