Document description | Preferred naming convention **YYMMDD is Version date of document** | Document Category | Preferred Filed Format |
Agreements | agreement.YYMMDD | Other | Any |
Assent Form | assent.YYMMDD | Consent/Assent Document (CF, AF, Info Sheet, Phone Script, etc.) | Word |
Billing Information Form | billing.YYMMDD | Other | Any |
Checklists | checklist.YYMMDD | Other | Any |
Consent Form | consent.YYMMDD | Consent/Assent Document (CF, AF, Info Sheet, Phone Script, etc.) | Word |
Correspondence | correspondence.YYMMDD | Other | Any |
Data Collection Form | datacollection.YYMMDD | Data Collection | Any |
Developmental Approval Request | developmental.YYMMDD | IRB Submission Form | |
Device Information (e.g. device manual, photos, etc.) | deviceinfo.YYMMDD | Drug/Device Information | Any |
Device Review Sheet | devicereview.YYMMDD | Drug/Device Information | Any |
Drug Information (e.g. package insert, sponsor info, etc.) | druginfo.YYMMDD | Drug/Device Information | Any |
Drug Review Sheet | drugreview.YYMMDD | Drug/Device Information | Any |
DSMB Reports | dsmb.YYMMDD | Post-Approval Monitoring | Any |
Exempt | exempt.YYMMDD | IRB Submission Form | PDF |
External Institution IRB Approval | irbapproval(institution).YYMMDD irbapproval(SchoolName).170627 | IRB Approvals | PDF |
Federal Wide Assurance Other Institution | fwa(location or multiple).YYMMDD | Other | |
FERPA Exception from Registrar | ferpa.YYMMDD | Other | Any |
Fiscal Approval Process Review Form | fap.YYMMDD | Ancillary Approval | Any |
FDA Form 1572 | fda1572.YYMMDD | Drug/Device Information | |
FDA IDE Documentation (e.g. IDE, NSR memo, sponsor info, etc.) | ide.YYMMDD | Drug/Device Information | |
FDA IND Documentation (e.g. IND, exemption letter, sponsor info, etc.) | ind.YYMMDD | Drug/Device Information | |
Focus Group Guides | focusgroup.YYMMDD | Data Collection | Any |
GDS Checklist | gdscklist.YYMMDD | IRB Submission Form | |
Grant/Funding | grantinfo.YYMMDD | Agreements/Funding | Any |
GDS Data Sharing Plan | gdsdataplan.YYMMDD | IRB Submission Form | |
HSP | hsp.YYMMDD | IRB Submission Form | |
ICH GCP Information | ichgcp | IRB Submission Form | Any |
Institution Review Form - Other | InstOther.YYMMDD | IRB Submission Form | |
Institution Review Form - WIRB | InstWIRB.YYMMDD | IRB Submission Form | PDF |
Institutional Biosafety Committee | ibc.YYMMDD | Ancillary Approval | PDF |
Investigator Brochure | ib.YYMMDD | Drug/Device Information | PDF |
Individual Investigator Agreement | IIA(last name).YYMMDD | IRB Approvals | |
Information Sheet | infosheet.YYMMDD | Consent/Assent Document (CF, AF, Info Sheet, Phone Script, etc.) | Word |
Interview Questions | interview.YYMMDD | Data Collection | Any |
IRB Authorization Agreements | IAA(site).YYMMDD | IRB Approvals | |
Investigator's Progress Report | ipr.YYMMDD | IRB Submission Form | |
Letter/Email to Participants | pptletter.YYMMDD | Participant Communications | Word |
Miscellaneous Documents | othermisc(description).YYMMDD | Other | Any |
Monitoring Report | monreport.YYMMDD | Post-Approval Monitoring | Any |
NHSR | nhsr.YYMMDD | IRB Submission Form | PDF |
Non-English Assent Form | assent(language).YYMMDD | Consent/Assent Document (CF, AF, Info Sheet, Phone Script, etc.) | Word |
Non-English Consent Form | consent(language).YYMMDD | Consent/Assent Document (CF, AF, Info Sheet, Phone Script, etc.) | Word |
Other Participant Communication (e.g. handouts, wallet cards, instructions, etc.) | pptcomms(description).YYMMDD | Participant Communications | Any |
Partial Waiver of Authorization - Screening/Recruitment | waiverpartial.YYMMDD | Consent/Assent Waiver Request | |
Pathology Release Form | path.YYMMDD | Ancillary Approval | |
Permission For Use (Specimens/Data) | usepermission.YYMMDD | Other | Any |
Problem Report | probreport.YYMMDD | Post-Approval Monitoring | PDF |
Problem Summary Sheet | probsummary.YYMMDD | Post-Approval Monitoring | Any |
Project Revision/Amendment Form | praf.YYMMDD | IRB Submission Form | |
Protocol Oversight Review Form | porf.YYMMDD | IRB Submission Form | |
Publications | publication.YYMMDD | Other | Any |
Radiation Safety Approval | rad.YYMMDD |
Ancillary Ap proval |
PDF |
Recruitment Advertisement | recruitmentad.YYMMDD | Participant Communications | Any |
Recruitment Flyer | flyer.YYMMDD | Participant Communications | Any |
Renewal Submission Supporting Documents (previous-approved consent forms/PRAFs/IPRs and the current HSP) | renewalpkt.YYMMDD | IRB Submission Form | |
Research Protocol | protocol.YYMMDD | Protocol/Scope of Work/Abstract | Any |
Response to IRB Query | response.YYMMDD | IRB Submission Form | |
Recruitment Communications | recruitmentcomms.YYMMDD | Participant Communications | Any |
Release of Drugs (Pharmacy Review) | pharmacyreview.YYMMDD | Ancillary Approval | PDF |
SPRF - Children | children.YYMMDD | Special Populations Form | PDF |
SPRF - Pregnant Women | pregnant.YYMMDD | Special Populations Form | |
SPRF - Prisoners | prisoners.YYMMDD | Special Populations Form | |
Site Permissions | sitepermission.YYMMDD | Other | Any |
Survey or Questionnaire | surveyquest.YYMMDD | Data Collection | Any |
Telephone Script | phonescript.YYMMDD | Participant Communications | Any |
Training Certificates | training.YYMMDD | IRB Training Documentation | PDF |
Verbal Consent Script | verbalconsent.YYMMDD | Consent/Assent Document (CF, AF, Info Sheet, Phone Script, etc.) | Word |
Waiver of Consent | waiverconsent.YYMMDD | Consent/Assent Waiver Request | |
Waiver of Documentation of Consent | waiverdocumentation.YYMMDD | Consent/Assent Waiver Request | |
Waiver of Authorization | waiverauth.YYMMDD | Consent/Assent Waiver Request | PDF |