ࡱ > ~ } e bjbj p ebeb5 N 0 0 8 L D | Q ( qC qC qC Q Q Q Q Q Q Q $ S V =Q - qC 1C 1C @ qC qC =Q I+ jQ #G #G #G qC F Q #G qC Q #G #G : L , M # C v L Q Q 0 Q L R (W -D (W M M (W 3M qC qC #G qC qC qC qC qC =Q =Q E r qC qC qC Q qC qC qC qC (W qC qC qC qC qC qC qC qC qC 0 B r : Observational Research Required Document Checklist All items must be made available to Waikato DHB Research Office prior to commencing any research involving patients, patient information, staff or sites of Waikato DHB. Documents can be made available via HDEC online application system (where appropriate) by authorising Waikato DHB to view your project file. Waikato DHB Registration# RD DocumentationCommentsDate Project RegistrationComplete Register Your Research form on website. You will be given a registration (RD) number.Project Proposal/ProtocolEmail to HYPERLINK "mailto:research@waikatodhb.health.nz" research@waikatodhb.health.nz Waikato DHB Approval of Research FormForm will be emailed to researcher following registration. Researcher to seek sign-off of the form, as indicated (relevant Clinical Director, Operations Director and Executive Director/COO.Waikato DHB Clinical Support Services Sign-off (if any) e.g. Clinical Records, Pharmacy, Labs, Radiology, Chief Data Officer, etc.Approval of Research form indicates which sign-offs required. Emails from approvers are acceptable as electronic sign-off or return signed form.Ethics Application Form & Approval letter if required (HDEC or Institution)Copy of the ethics application and ethics approval letter is required (electronic is fine). For HDEC: Locality Authorisation must be requested in the online HDEC system : Research@Waikatodhb.health.nz. FinanceResearch involving costs to the DHB and/or income/funding/grant: requires a Trial budget excel form to be completed. Other trials registration indicates the cost to the DHB of undertaking the research (researcher time, extra clinic appointments, consumables.)ProcurementFor any study involving equipment or consumables not already approved by Waikato DHB, log a portal request #521. Include copy of approval email with Approval of Research form. Guidance available from Research Office.Privacy Impact Assessment and/or Cloud AssessmentIf identifiable data is being collected and shared with other institutions, either within New Zealand or internationally, one or both of these documents may be required. Research Office can advise.Participant Information Sheet, Consent form, Questionnaire, letters of invitation, advertisements (if any)Final Waikato DHB version required.Funding Contract (if any)Following internal legal review, the Chief Medical Officer (CMO) or authorised delegate must sign all research contracts on behalf of Waikato DHB. Principal investigator to sign b e f o r e C M O E v i d e n c e o f c u l t u r a l c o n s u l t a t i o n C o m p l e t e M o r i C o n s u l t a t i o n F o r m ( a v a i l a b l e o n t h e w e b s i t e ) p l u s t h e T i s s u e f o r m ( i f a p p l i c a b l e ) a n d r e t u r n t o R e s e a r c h O f f i c e . A n y q u e r i e s , p l e a s e c o n t a c t R e s e a r c h O f f i c e ( H Y P E R L I N K " m a i l t o : r e s e a r c h @ w a i k atodhb.health.nz" research@waikatodhb.health.nz) Waikato DHB Access to Information DeclarationRequired for any non-Waikato DHB staff accessing Waikato DHB patients, patient information or premises. Any queries should be directed to Waikato DHB Research Office by email research@waikatodhb.health.nz WaikatoDHB Observational research checklist v.9 Jan2020 ( ) 3 4 h j k r s v ʸ|l\L<- h8 h/ CJ OJ QJ ^J h8 h|8) 5CJ OJ QJ ^J h8 hX 5CJ OJ QJ ^J h8 h 5CJ OJ QJ ^J h8 h\ 5CJ OJ QJ ^J h8 5CJ OJ QJ ^J h8 hB1 CJ OJ QJ ^J h8 hB1 CJ OJ QJ ^J h8 hU CJ OJ QJ ^J aJ "h8 hU 5>*OJ QJ ^J aJ "h8 h'B2 5>*OJ QJ ^J aJ "h8 h 5>*OJ QJ ^J aJ "h8 h4-A 5>*OJ QJ ^J aJ 3 4 j k $ $If a$gdx $ $If a$gd\ 9gd87 gdB1 gdU $a$gdb4 B C u v ƸƩudO>O+O $h/V h