Insert letterhead of institution/organisation

Date

Ethics Manager

Research Office

Level 13, Kolling Building

Royal North Shore Hospital

St Leonards NSW 2065

NSLHD file reference: XXXX-XXXM or RESP/14/xx

Study Title: xxx

AURED HREC reference: HREC/xx/HAWKE/xxx

Dear Ellie

Please find attached quarterly / six monthly / annual line listings core safety update / other document type for the above study for the period insert dates.

The line listings have been reviewed and I recommend

no changes are required to the study documentation

OR

changes are required to the Participant Information Sheet and Consent Form/s, study protocol or ongoing conduct of the study. Amended forms have been submitted with this report / are pending / other

any additional information

If the HREC Executive Committee has any questions regarding the above please do not hesitate to contact XXXXXXX.

Yours sincerely

Principal/Coordinating Investigator

Notes for completion (delete prior to submission)

1.  This letter MUST be signed by the Coordinating Investigator of the study, however, the contact listed may be a study coordinator or similar.

2.  Text marked in yellow requires modification/completion by the person filling in this template

NSLHD HREC – Line listings – Template updated May 2014 1