Unblinding Information

Most clinical scenarios, including suspected allergic reaction, are managed by stopping the the doxycycline/placebo capsules. A request on the grounds of safety can be made by any clinician involved in the medical care of the women.

If unblinding is considered an emergency contact the clinical team on 07385 029221, 24/7 service.

Please have ready: your name, organisation, role, valid NHS email address, participant trial ID and drug-pack number.

Investigator Site File and Pharmacy Site File Documents

The documents to be printed for your Investigator and Pharmacy site files can be accessed via the following links:

ISF documents

PSF documents

The documents have been arranged into folders for each section of the ISF/PSF. The documents can all be downloaded at once into a zip folder, or you can download individual documents:

• To download all of the documents at once into a zip folder, click on 'CERM ISF' (or 'PSF') so that it is highlighted, then click on the 'Download' button. After a few moments the zip folder will begin to download.
• To download individual documents, navigate to the section and document you wish to download. Click on the title of the document you require and it will begin to download. You can also tick the checkboxes to download a couple of documents from the same section at once.