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 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 | ​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​ |