Approval processes and forms

In order to obtain approval for clinical research to commence most of the following will be required.

Please contact Health Research South for assistance.

Clinical research approval

• Clinical Research Approval Form (CRAF) (doc)
  this document is the central approval document for research involving patients, patient notes or facilities of the SDHB
• Clinical Research Approval Form Guidelines (doc)

Also the following may be required:

• Clinical Study Costings Template or CCW (xls)
• Research Resource Request Form (doc)
  for quotes of SDHB support services, print only required pages
• Alert Sheet (doc)
• Patient Information Sheet and Consent Form
  • Localised Advocacy Details (doc)
    to be included in Patient Information Sheet
• Ethical Application form including Form A or Form B
• Ethical Approval Letter
• Contract and Indemnity
• Study Protocol

Financial processes

• Guidelines to Managing Research Project Accounts & Research Group Accounts held by the Southern DHB (doc)
• Request for SDHB Research Project Account (doc)
• Request for SDHB Research Group Account (doc)
• Request for SDHB Invoice (doc)
• Research Project Account Transfer Form (doc)

Southern Community Laboratories processes

For clinical trials requiring local laboratory services, please see the following from Southern Community Laboratories:

• Guidelines to SCL Research Resource Request Form (pdf)
• SCL Research Resources Request Form (doc)
• SCL Price List (pdf)

The following may also assist:

• Reference Intervals - Haematology or Chemistry (pdf)
• Accreditation Certificate (pdf)