The following information outlines the requirements which must be included in all applications submitted to Bellberry as per Section 5.2.5 of the National Statement.
- Bellberry HREC expects all applications to refer and adhere to the NHMRC National Statement of Ethical Conduct in Human Research (2007) and refer to relevant local legislation.
- the Protocol title, protocol identifying number and date are to be included. Any amendment(s) should also bear the amendment number(s) and date(s).
- all documents need to be saved in PDF format with the file name stating the Version no. and date and attached with your application via the eProtocol system. A footer is required to assist with this information.
- applications should be written in plain English without the use of technical jargon. The use of abbreviations, even relatively well known ones, should be avoided.
Protocols for Clinical Studies
- Please see the Protocol Preparation Guide for protocol guidance for clinical studies.
- Another source of useful information for clinical studies is the ICH Guideline for Good Clinical Practice
Protocols for Non-Clinical Studies