Trial documents

Download Trial Documentation (password protected)

Links to the trial’s current forms and documents are provided below. For any documentation that cannot be found on this page, please contact the OCTAVE Trial Office.

If there has been a recent amendment to the trial, please ensure that you have obtained R&D approval before using the updated versions of these documents.

Some of the documents on this page are large files. If you are having issues viewing the documents in your web browser, please right click and ‘Save link as…’ to read them in a PDF viewer such as Adobe Reader.

Trial protocol and supplementary documents

Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the study. Patients who are interested in taking part in the study are advised to talk to their health care professional. Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.

Protocol (PDF, 1.40mb) You do not need a username and password to access this document

Protocol synopsis (PDF, 426kb)

Patient Documents

Patient information sheet and Informed consent form

PIS (PDF, 640kb)

ICF (PDF, 594kb)

GP letter (PDF, 579kb)

PIS and ICF Addendum (PDF, 604kb)

please note: all PIS, ICFs and GP Letters should be localised using hospital headed paper.

Pharmacovigilance

SAE form (PDF, 739 kb)

SAE form completion guidelines (PDF, 559kb)

Investigational Medicinal Products Reg 174 Information For UK Healthcare Professionals

The latest Reg 174 Information For UK Healthcare Professionals for the Investigational Medicinal Products used in this trial are available below. Please ensure the latest versions are available in the Investigator Site File.

Reg 174 information Pfizer (PDF, 380kb)

Reg 174 Information Astra Zeneca (PDF, 146kb)

Reg 174 Information Moderna (PDF, 276kb)

Version control checklist

The version numbers and dates of all documents used for the trial are captured on the Investigator Site File Version Control List. Link to this Version Control List used in this trial is below.

Version control checklist (PDF, 18kb)

Sample collection

Lab manual (PDF, 1.56mb)

Lab Manual for Group 1 - 6 & 12 Months (PDF, 1.19mb)

Samples handling manual (PDF, 1.47mb)

Lab forms

Labratory sample receipt (PDF, 359kb)

Octave sample tracker (Excel, 36kb)

Shipment manifest (Excel, 36kb)

Blood processing sheet for group 1 (PDF, 342kb)

Blood processing sheet for group 2 (PDF, 349kb)

Change of Staff

If there are any changes to the staff working on this trial, please complete the relevant staff Registration Form below. Please also ensure that the Site Signature and Delegation Log (SS&DL) is updated and return both documents to the OCTAVE Trial Office (via e-mail) link.

Site registration form (PDF, 33kb)

Investigator registration form (PDF, 520kb)

Staff registration form (PDF, 607kb)

Site signature & delegation log (PDF, 227kb)

Data collection

Serious adverse event form (PDF, 739kb)

Amended documents

Below are links to all of the amendments made to this trial that are relevant to all sites. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

SA04 Amendment Rec Form (PDF, 104kb)

SA04 Amendment Tool (PDF, 343kb)

SA04 HRAHCRW Approval (PDF, 23kb)

SA04 MHRA Acceptence (PDF, 147kb)

SA04 Cover Letter REC (PDF, 227kb)

SA04 Cover Letter MHRA (PDF, 227kb)

SAM01 Amendment Tool signed (PDF, 314kb)

SAM01 Cover Letter MHRA (PDF, 230kb)

SAM01 Cover Letter Rec (PDF, 464kb)

SAM01 HRAHCRW Approval (PDF, 123kb)

SAM01 MHRA Acceptence (PDF, 141kb)

SAM01 Rec form (PDF, 503kb)