When an additional site is approved after the initial study’s approval, Bellberry administration will upload all previous approval letters to eProtocol page 7 of the additional site’s application. The additional site is responsible for checking that the approved documents match the documents on file. If the site has any documents that do not match those approved (e.g. they have a more recent version of the protocol), the site is responsible for contacting the sponsor to determine which of the approved sites will be responsible for submitting an amendment.

Please refer to BA F1.1.7 HREC process flowchart for further information.