Naming Conventions - Files Uploaded in IRB7

CENTRAL IRB

Naming Conventions - Files Uploaded in IRB7

Document Upload Tips:

•  The name given to the file when it is uploaded is the name that will

appear on the approval letter

•  Add version dates to the protocol, consent, HIPAA, and recruitment

documents.

•  Use VERSION DATE and not just a number

•  The consent and HIPAA forms must be submitted as MS WORD documents. All others

can be separate PDF documents.

•  All documents must be unprotected; password protected items will not be accepted.

Document Naming Examples:

•  CReATe Protocol [if applicable, study sponsor name] Addendum 1 v081216

•  Modification v081216

•  Investigator Protocol v081216

•  CReATe [UM or other site] Main ICF (language i.e. ENG/SPN) Tracked v081216

•  CReATe {UM or other site] Combined ICF HIPAA (language i.e. ENG/SPN) v081216

•  CReATe [UM or other site] Assent (language i.e. ENG/SPN) v081216

•  CReATe [UM or other site] (tissue/main/focus group/control etc) ICF (language i.e ENG/SPN) v081216

•  CReATe [UM or other site] short form (language i.e. ENG/SPN) v081216

•  CReATe Recruitment material/s (Dear Patient Letter/Flyer/Advertisement/RadioAd etc) (language i.e. ENG/SPN)

•  CReATe Study questionnaires/surveys (phone survey/SurveyMonkey/RedCap etc) v081216

•  CReATe (Drug/Device Name) Investigator Drug/Device Brochure v081216

•  CReATe Biological Specimens/Drug v081216

Acceptable Acronyms:

•  ICF - consent form document

•  Short Form - short form consent document

•  IB- investigator drug/device brochure

•  ENG – English

•  SPN – Spanish