INFORMATION FOR RESEARCHERS

On this page you can access the trial Standard Operating Procedures and find the key documents you need in order to keep the trial site files up to date.

Authorised researchers will also be able to access the Trial Management Database HERE from September 2013.

The OSAC trial management database must only be accessed from computers supported by an OSAC collaborating centre, on the host organisation premises. For all permissions queries contact the Bristol trial team.

Patient Safety

Patient safety reporting for the OSAC trial is overseen by the University Hospitals Bristol NHS Foundation Trust. All members of the OSAC trial team should receive training in patient safety reporting from the Bristol Trial Research Nurse or Trial Manager. The key documents with which all researchers should be familar are:

  1. Serious Adverse Event Reporting - summary instructions
  2. SAE Initial Report Form This form must be completed with as much information as is available, and faxed to UH Bristol within 24 hours of becoming aware of the event having occurred.
  3. OSAC Trial Emergency Unblinding - summary instructions

If you have any queries about patient safety, please contact us.

Ethics

OSAC is reviewed by the Central Bristol REC, reference 12/SW/0180. The following documents are available:

  1. Initial ethical approval for OSAC (25 October 2012)
  2. REC approval for substantial amendment 1 (5 February 2013)
  3. REC approval for substantial amendment 2 (14 June 2013)
  4. REC approval for substantial amendment 3 (07 Nov 2013)
  5. Summary of current versions of all trial documents

Go to the clinicians page for copies of the current versions of the ethically approved documents.

MHRA

OSAC is licensed by the MHRA as a Type A trial (comparable to the risk of standard medical care). The following documents are available:

  1. Initial MHRA acceptance for OSAC (24 October 2012)
  2. MHRA acceptance letter for substantial amendment 1 (26 February 2013)
  3. MHRA acceptance letter for substantial amendment 3 (19 Dec 2013)

The trial sponsor has advised that further amendments which do NOT have a "significant impact on the safety or physical or mental integrity of the clinical trial subjects, or the scientific value of the clinical trial" do not need to be notified to the MHRA, therefore MHRA acceptance of amendment 2 is not required.

R&D approvals

Please contact the Trial Manager for copies of the R&D approval documentation for any participating site.

Sponsorship letter

Please contact the Trial Manager for a copy of the current sponsorship letter.

Trial insurance

Please contact the Trial Manager for a copy of the current sponsorship letter.

Standard Operating Procedures

The following SOPs can be downloaded:

  1. OSAC Trial Drug Handling - full SOP
  2. OSAC Trial Emergency Unblinding - summary instructions
  3. OSAC Trial Emergency Unblinding - full SOP
  4. Serious Adverse Event Reporting - summary instructions
  5. Serious Adverse Event Reporting - full SOP
  6. Reporting Protocol Deviations - full SOP
  7. Fax Transmissions
  8. Fax Transmissions Cover Sheet

Key logs for the site file

All of the logs that must be kept as part of the trial documentation are provided at set-up within the GP Practice site file. If additional copies are required, the following can be downloaded from this page:

  1. OSAC Trial Screening Log
  2. OSAC Trial GP Practice Delegation Log
  3. OSAC Trial Patient Pack Requisition and Transfer Form
  4. OSAC Trial Temperature Monitoring Log
  5. OSAC Trial Weekly SAE Check Log

FAQs and other useful references

The following documents may be helpful, in addition to those provided on the clinician's page:

  1. OSAC Trial Frequently Asked Clinical Questions
  2. OSAC Trial Patient Identification Labeling Instructions
  3. OSAC Trial Online Database Access Instructions