Approval Processes and Forms

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

Please contact the HRO for assistance.

Clinical Research Approval

• Clinical Research Approval Form (CRAF) (doc)(new form under trial, feedback welcome)
  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 SouthernDHB (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 Pricelist (pdf)

The following may also assist:

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