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Documen​t 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 ​PDF
​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 ​PDF
​​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 ​PDF
​FDA IDE Documentation (e.g. IDE, NSR memo, sponsor info, etc.)​ ​ide.YYMMDD​ ​​Drug/Device Information ​PDF
​FDA IND Documentation (e.g. IND, exemption letter, sponsor info, etc.) ​ind.YYMMDD ​Drug/Device Information ​PDF
​Focus Group Guides ​focusgroup.YYMMDD ​​Data Collection Any​​
GDS Checklist​ ​gdscklist.YYMMDD ​IRB Submission Form ​PDF
Grant/Funding​ ​grantinfo.YYMMDD ​Agreements/Funding ​​Any
​GDS Data Sharing Plan ​gdsdataplan.YYMMDD ​IRB Submission Form ​PDF
​HSP ​hsp.YYMMDD IRB Submission Form​​ ​​PDF
​ICH GCP Information ​ichgcp IRB Submission Form​​ ​Any​
​Institution Review Form - Other ​InstOther.YYMMDD ​IRB Submission Form ​PDF
​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 ​​PDF
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 ​PDF
​Investigator's Progress Report ​ipr.YYMMDD ​IRB Submission Form ​PDF
​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​​ ​PDF
​Pathology Release Form​​ path.YYMMDD​ ​Ancillary Approval​ ​PDF
​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 ​PDF
​​Protocol Oversight Review Form ​porf.YYMMDD​ ​IRB Submission Form​ ​PDF
​Publications ​publication.YYMMDD ​Other Any​
Radiation Safety Approval​ ​rad.YYMMDD

Ancillary Ap


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 ​PDF
Research Protocol​ protocol.YYMMDD​ Protocol/Scope of Work/Abstract​ ​Any​
Response to IRB Query response.YYMMDD​ ​IRB Submission Form ​PDF
​​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​ ​PDF
SPRF - Prisoners​ ​prisoners.YYMMDD Special Populations Form​ ​PDF
​​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 verbal​consent.YYMMDD ​Consent/Assent Document (CF, AF, Info Sheet, Phone Script, etc.)​ ​Word
​Waiver of Consent waiverconsent.YYMMDD​ Consent/Assent Waiver Request​ ​PDF
​Waiver of Documentation of Consent waiverdocumentation.YYMMDD​ ​Consent/Assent Waiver Request ​PDF
​Waiver of Authorization waiverauth.YYMMDD​ Consent/Assent Waiver Request​ PDF​