Information for clinicians
- Inclusion and exclusion criteria
- Ideas for successful recruitment
- Trial Flow Diagram
- Trial Documents
- OSAC trial Case Report Form (CRF)
- Database Access Instructions
- Patient packs
- Clinical Contacts
- Contact the study team
- More about OSAC
Total number of patients recruited: 398
The OSAC trial database must only be accessed from computers supported by an OSAC collaborating institution (University or GP Practice), on the host organisation premises. For all permissions queries contact the Bristol trial team.
Information for clinicians
You can download the current study protocol by clicking here.
A summary of the study eligibility and exclusion criteria can be downloaded by clicking here.
You can find suggestions from successfully recruiting GP practices, about factors that enable OSAC trial recruitment, by clicking here.
A summary of the trial processes can be downloaded here.
Here you can access local versions of study documents (select your local study centre). If the document you need is not listed, please contact your local study team.
|Trial poster||click here|
|Consent form||Please contact the trial team|
|Consent to contact form
(must be used for any home recruitment visits)
|Please contact the trial team|
|Full patient information booklet||click here|
|Summary patient information sheet||click here|
|Screening log||click here|
|SAE reporting form||click here|
|SAE reporting procedure||click here|
|Withdrawal form||click here|
|Patient Symptom Diary (for information only)||click here|
|3 month primary care medical notes review form (for information only)||click here|
If you run out of paper versions of the trial Case Report Form documents, in the first instance contact your local study team. In an emergency, authorised recruiting staff can print additional copies using the links below.
|Case Report Form||
Face-to-Face Patient Eligibility Check
Clinical Examination and Diagnosis
Symptoms, Signs and Medical History
Click here for instructions on how to start off the process of entering data into the online database, including use of the online Screening ID.
If you have a clinical query relating to the management of a patient recruited into the OSAC trial, you can contact the trial Principal Investigators here.
For any other query relating to the OSAC trial, please contact your local trial team.
The OSAC trial is funded by a grant of £871,958 from the Department of Health's National Institute for Health Research (NIHR) National School for Primary Care Research.
The OSAC trial is sponsored by the University of Bristol.
The safety of patients enrolled onto the OSAC trial is monitored by the University Hospitals Bristol NHS Foundation Trust.
The OSAC trial is governed by an independent Steering Committee. For information about the work and membership of the Committee please contact the Trial Manager, Harriet Downing, tel: 0117 331 3906 / e-mail: firstname.lastname@example.org.
A graph of current recruitment against target will be available here from September 2013.
The OSAC trial team provides training for all recruiting GP sites, and can put you in touch with providers of other relevant training e.g. ICH-GCP. For further information about ICH - GCP training please contact your local PCRN.