DAIDS PROTOCOL REGISTRATION MANUAL
DAIDSBethesda, MD USAManualProtocol Registration ManualEffective Date: 03/01/19Document No.: MAN-A15-OPC-001.00EffectiveDAIDS PROTOCOLREGISTRATION MANUALOffice for Policy in Clinical ResearchOperations Division of AIDS
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I. IntroductionEffectiveThe Division of AIDS (DAIDS) Office for Policy in Clinical Research Operations (OPCRO) hasestablished a protocol registration manual that details, in a step-wise manner, the protocolregistration process to ensure that all clinical research sites (CRSs) conducting NationalInstitute of Allergy and Infectious Disease (NIAID)DAIDS-supported and/or -sponsored clinicalresearch do so in accordance with DAIDS Clinical Research Policies and Standard Proceduresin addition to all applicable regulations for human subjects protection and the use ofinvestigational drugs, biologics and/or devices. Each CRS will complete the protocol registrationprocess for all clinical research supported and/or sponsored by NIAID (DAIDS) that is reviewedby CSRC or PSRC. Submission of an incomplete package by failing to include all requireddocuments for protocol registration at the time of submission to the DAIDS PRO will result inprocessing delays until all the required documents are received.The DAIDS Protocol Registration Manual is a reference tool to help CRSs successfullycomplete the DAIDS protocol registration process. This manual explains the different types ofprotocol registration submissions as well as a list of the required documents for each type ofsubmission. Critical pointers are provided in the NOTES throughout the DAIDS ProtocolRegistration Manual. Failure to include any required documents for protocol registration at thetime of submission to the DAIDS PRO will result in processing delays until all the requireddocuments are received.The protocol registration process begins once a protocol has completed the DAIDS protocoldevelopment requirements. All protocols must receive final DAIDS approval either after DAIDSClinical Sciences Review Committee (CSRC) or Prevention Sciences Review Committee(PSRC) and after regulatory review and DAIDS Medical Officer sign-off. For protocolsconducted under a DAIDS-held Investigational New Drug (IND) Application, the final DAIDSapproved version of the protocol must be submitted to the U.S. Food and Drug Administration(FDA).The DAIDS protocol registration process verifies that CRSs have received the necessaryInstitutional Review Board (IRB)/Ethics Committee (EC) and other applicable Regulatory Entity(RE)/Regulatory Authority approvals and have provided to DAIDS all documentation pertainingto investigator qualifications and responsibilities that are required by The InternationalConference on Harmonisation of Technical Requirements for Registration of Pharmaceuticalsfor Human Use (ICH), the U.S. federal regulations and the National Institutes of Health (NIH).The DAIDS protocol registration process also verifies that site-specific informed consent formscontain the necessary information to comply with ICH, and the U.S. federal regulations. Thisincludes the basic and additional informed consent form elements as required by U.S. federalregulations at 45 CFR 46.116 and 21 CFR 50.25.1
II. Summary of ChangesThis manual has been reviewed for accuracy and updated to meet 508 compliance guidelines.Several sections have been updated to be consistent with current NIAID (DAIDS) requirements.Key changes to note in this version of the Manual include:1. DAIDS requirement of Protocol Signature Page (PSP) to document the commitment ofthe Investigator of Record (IOR) to conduct the trial in compliance with regulations/Lawsand ensure compliance with ICH E6 GCP 4.5.1 and 5.6.3.2. The requirement to submit the Clinical Trial Application (CTA) Form/documentation thatidentifies the study sponsor.Effective3. The requirement to submit translation certificate (or translation documentation) confirminga true and accurate translation of documents from local language into English language.4. Clarification regarding staff that must be listed on the Form FDA 1572 an/or DAIDS IORForms in compliance with U.S. regulations and ICH E6 standards.5. Adjusted the timeline to submit updated DAIDS IOR Forms and Form FDA 1572s from30 days to 15 days.6. Formatting changes and hyperlinks added to improve navigation of the manual.7. Clarified requirements regarding documents required to be submitted to DAIDS fromIRBs, ECs, REs, and Regulatory Authorities.8. Provide guidance on the use of electronic signatures.9. Change to requirements regarding justifications for non-submission of RegulatoryAuthority approvals of full version protocol Amendments and Letter of Amendments(LOA).10. Clarification of Continuing Review requirements based on the October 2018 FDAguidance, 21 CFR 56.109 and 45 CFR 46.109.This Manual supersedes the version 3.0 dated April 2015.2
III. Protocol Registration Required Documents by Submission TypeDAIDS reviews and approves the latest version of each protocol and Sample Informed ConsentForm (ICF) before distribution to the CRSs. CRSs are required to submit the initial version andall subsequent versions of a NIAID (DAIDS) -supported and/or -sponsored protocol, includingthe DAIDS-approved Sample ICF and site-specific ICFs, to their reviewing IRB/EC and otherapplicable RE/Regulatory Authority(ies) for review and approval.EffectivePrior to implementing the protocol and enrolling participants, a CRS must receive approval fromtheir IRB/EC and other applicable RE/ Regulatory Authorities. In addition, the CRS mustsuccessfully complete the DAIDS protocol registration process. When cleared to open toenrollment, a CRS will be notified by the appropriate DAIDS scientific program (e.g.,Program/Contracting Officer Representative), Operations Center or Data Management Centerwhen enrollment may begin.Detailed information on specific requirements for each required document for protocolregistration is included in sub-sections A-H of Document Requirements (Concise) of the manual.3
A. Submission Requirements by Submission TypeSubmission RequirementsDocument RequirementPageForm FDA 1572 for IND studies and DAIDS IORForm for Non-IND studiesForm FDA 1572/DAIDS IOR Form10IOR CVCurriculum Vitae11IOR Medical License (License equivalent)Medical License12IRB/EC Approval LettersIRB/EC/RegulatoryEntity(ies)/Regulatory ty(ies)/Regulatory Authority(ies)documentation12IRB/EC Submissions LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12All IRB/EC ory ty(ies)/Regulatory Authority(ies)documentation12Clinical Trial Application Form/documentRegulatory Entity (RE)/Regulatory AuthorityApproval LettersIRB/EC/RegulatoryEntity(ies)/Regulatory ty(ies)/Regulatory Authority(ies)documentation12RE/Regulatory Authority Submission LettersRE/Regulatory ntity(ies)/Regulatory ty(ies)/Regulatory Authority(ies)documentation12All RE/Regulatory Authority CorrespondenceIBC Approval Letter and applicablecorrespondence (when applicable)Institutional Biosafety Committee (IBC)13Protocol Signature PageProtocol Signature Page (PSP)14EffectiveSubmissionTypeDocumentation of Pediatric risk/benefit categoryper 45 CFR 46 and 21 CFR 50(if applicable)Initial Registration4
Submission RequirementsDocument RequirementPageSite Specific Informed Consent(s) all applicable languages. All ICFs required by theprotocol are required to be submitted orjustification for the omission is required.Site Specific Informed Consents15Site Specific Informed Assent(s) all applicable languagesSite Specific Informed Consents15Translation Certificate (if applicable)Translation requirements36Translation Confirmation Documentation(if applicable)Translation ory Authority(ies)documentation12IRB/EC Approval LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12IRB/EC Submission LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12All IRB/EC CorrespondenceDocumentation of Pediatric risk/benefit categoryper 45 CFR 46 and 21 CFR 50(if applicable)IRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12RE/Regulatory AuthorityApproval/Acknowledgement LettersIRB/EC/RegulatoryEntity(ies)/Regulatory ty(ies)/Regulatory Authority(ies)documentation12RE/Regulatory Authority Submission LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12All RE/Regulatory Authority CorrespondenceProtocol Signature PageProtocol Signature Page (PSP)14Site Specific ICF all applicable languages. All previously approvedICFs must be submitted or justification providedfor their omission must be provided. Any newICFs added within the protocol ICFs must besubmitted as an Additional ICF type orjustification provided for their omission must beprovided.Site Specific Informed Consents15EffectiveSubmissionTypeAmendment5
Submission RequirementsDocument RequirementPageSite Specific Informed Assent(s) all applicable languages. All previously approvedAssents must be submitted, or justificationprovided for their omission must be provided.Any new Assents required must be submitted asAdditional ICF types or justification provided fortheir omission must be provided.Site Specific Informed Consents15Translation Certificate (if applicable)Translation requirements36Translation Confirmation Documentation(if applicable)Translation ory Authority(ies)documentation12IRB/EC Approval LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12IRB/EC Submissions LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12All IRB/EC CorrespondenceDocumentation of Pediatric risk/benefit categoryper 45 CFR 46 and 21 CFR 50(if applicable)IRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12RE/Regulatory AuthorityApproval/Acknowledgement LettersIRB/EC/RegulatoryEntity(ies)/Regulatory ty(ies)/Regulatory Authority(ies)documentation12RE/Regulatory Authority Submission LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12RE/Regulatory Authority CorrespondenceSite Specific ICFs all applicable languages. Any revised ICFsshould be submitted as a Site Revised ICFsubmission along with the LOA. Any newICFs added within the protocol ICFs must besubmitted as an Additional ICF type orjustification provided for their omission mustbe provided.Site Specific Informed Consents15EffectiveSubmissionTypeLetter ofAmendment(LOA)6
Submission RequirementsDocument RequirementPageSite Specific Informed Assent(s) all applicable languages. Any revised Assentforms should be submitted as a Site RevisedICF submission along with the LOA. Any newAssents required must be submitted asAdditional ICF types or justification providedfor their omission must be provided.Site Specific Informed Consents15Protocol Signature PageProtocol Signature Page (PSP)14Translation Certificate (if applicable)Translation requirements36Translation Confirmation Documentation(if applicable)Translation requirements36EffectiveSubmissionTypeForm FDA 1572 for IND studies and Form FDA1572 or IOR Form for Non-IND studiesForm FDA 1572/DAIDS IOR Form10IOR CVCurriculum Vitae11IOR Medical License (License equivalent)Medical License12IRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12IRB/EC Approval LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12IRB/EC Submissions LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12All IRB/EC CorrespondenceRE/Regulatory AuthorityApproval/Acknowledgement LettersIRB/EC/RegulatoryEntity(ies)/Regulatory ty(ies)/Regulatory Authority(ies)documentation12RE/Regulatory Authority Submission LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12All RE/Regulatory Authority CorrespondenceIBC Approval Letter and applicablecorrespondence (when applicable)Institutional Biosafety Committee (IBC)13Protocol Signature PageProtocol Signature Page (PSP)14Translation Certificate (if applicable)Translation requirements36AdministrativeRegistration7
SubmissionTypeDocument RequirementPageTranslation Confirmation Documentation(if applicable)Translation requirements36Form FDA 1572 for IND studies and Form FDA1572 or IOR Form for Non-IND studiesForm FDA 1572/DAIDS IOR Form10IOR CVCurriculum Vitae11IOR Medical License (License equivalent)Medical License12Protocol Signature PageProtocol Signature Page (PSP)14IRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12IRB/EC Approval LettersEffectiveChange ofInvestigatorSubmission RequirementsContinuingReviewSite InitiatedRevised ICFsIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12IRB/EC Submission LettersIRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12All IRB/EC ory Authority(ies)documentation12IRB/EC Approval Letters12IRB/EC Submission LettersIRB/EC/RegulatoryEntity(ies)/Regulatory (ies)/Regulatory Authority(ies)documentation12All IRB/EC CorrespondenceRE/Regulatory Authority/Acknowledgement Letters(if applicable)IRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12RE/Regulatory Authority Submission Letters(if applicable)IRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12RE/Regulatory AuthorityApproval/Acknowledgement Letters(if applicable)IRB/EC/RegulatoryEntity(ies)/Regulatory Authority(ies)documentation12Site Specific ICFs - all applicable languagesSite Specific Informed Consents15Site Specific Informed Assent(s) all applicable languagesSite Specific Informed Consents15Translation Certificate (if applicable)Translation requirements368
SubmissionTypeDocument RequirementPageTranslation Confirmation Documentation(if applicable)Translation requirements36Updated FormFDA 1572 orDAIDS IOR FormForm FDA 1572 for IND studies and Form FDA1572 or IOR Form for Non-IND studiesForm FDA 1572/DAIDS IOR Form10DeregistrationRequest stating that the CRS no longer intendsto participate in the protocol(s) and/or A Copy ofthe IRB/EC closure/termination letter for theprotocol if the protocol has been closed with theIRB/EC at the time of deregistrationDeregistration57Suspension orTermination ofIRB/EC ApprovalDocumentation from the IRB/EC that identifiesthe reason for suspension or terminationSuspension or Termination of IRB/ECApproval31EffectiveSubmission Requirements9
IV. Document Requirements (Concise)A. Form FDA 1572/DAIDS IOR FormGeneral RequirementDetailed RequirementSection 1 - Name and Address ofInvestigator of Record (IOR)Complete legal name (first and last name) andaddress of the IOR at the CRS that is responsiblefor the conduct of the clinical trial. The completelegal name of the IOR and the IOR’s completeoffice address (complete physical location/streetaddress/country)Section 1 - Name andAddress of Investigator ofRecord (IOR)Section 2 - Education, Training,and ExperienceRequires the IOR to check the appropriate boxon how they plan to verify their education, trainingand experience that qualifies them as an expert inthe clinical investigation of the study product (drugor biologic) being testedSection 2 - Education,Training, and ExperienceSection 3 - Name and Addressof Location(s) Where the StudyWill be conductedComplete name and address of all locations wherethe clinical trial will be conducted and where clinicaldata will be generated or collected. The completename and physical address of all the locations(medical school, hospital, clinics, additionallocations, or research facility)Section 3 - Name andAddress of Location(s) wherethe Study will be conductedSection 4 - Name and Addressof Clinical LaboratoryComplete name(s) and complete physical address(including country) of ALL clinical laboratories ortesting facilities which will be used for the clinicaltrial to process study related and/or study definedsamples that will directly contribute to or support theclinical trialSection 4 - Name andAddress of ClinicalLaboratorySection 5 - Institutional ReviewBoard (IRB)/Ethics Committee(EC) and All Other RegulatoryEntity(ies) (RE)/ RegulatoryAuthority(ies))and Institutional BiosafetyCommittees (IBCs)Complete name and address of all IRBs, ECs andother applicable Regulatory Authority(ies) and IBCswhich are responsible for the review and approvalfor the conduct of clinical trials at a CRSSection 5 - InstitutionalReview Board (IRB)/EthicsCommittee (EC) and AllOther Regulatory Entity(ies)(RE)/RegulatoryAuthority(ies) and InstitutionalBiosafety Committees (IBCs)Section 6 - Names ofSub-InvestigatorsComplete legal name (first and last name) of studystaff at a CRS responsible for making a “direct andsignificant contribution to data”Section 6 - Names of SubInvestigatorsSection 7 - Protocol Nameand Protocol NumberDAIDS ES/Network protocol ID numberand the complete protocol titleSection 7 - Protocol Nameand Protocol NumberSection 8 - ClinicalProtocol InformationLeave blankSection 8 - Clinical ProtocolInformationSections 9 - CommitmentsRead and understandSections 9, 10 and 11EffectiveSection10
General RequirementDetailed RequirementSection 10 - DateHandwritten or electronic date is acceptable. Ifutilizing electronic date, an electronic signaturemust be utilized, and the electronic date and thedate identified in the electronic signature mustcorrespond. See Signature Requirement Guidanceregarding electronic signature requirements.Sections 9, 10 and 11Section 11 - Signature ofInvestigatorHandwritten or electronic signature is acceptable. Ifutilizing electronic signature, an electronic datemust be utilized and the electronic date and thedate identified in the electronic signature mustcorrespond See Signature Requirement Guidanceregarding electronic signature requirements.Sections 9, 10 and 11EffectiveSectionB. Curriculum VitaeGeneral RequirementDetailed RequirementSubmitted (or on file and less than two years old)Name on the CV matches IOR identified on currentForm FDA 1572 or DAIDS IOR FormComplete (all pages submitted, and the documentis legible)Curriculum Vitae (CV)Dated: Handwritten or electronic date is acceptable.If utilizing electronic date, an electronic signaturemust be utilized, and the electronic date and thedate identified in the electronic signature mustcorrespond. See Signature Requirement Guidanceregarding electronic signature requirements.Signed: Handwritten or electronic signature isacceptable. If utilizing electronic signature, anelectronic date must be utilized and the electronicdate and the date identified in the electronicsignature must correspond See SignatureRequirement Guidance regarding electronicsignature requirements.11Curriculum Vitae (CV)
C. Medical LicenseReview RequirementDetailed RequirementsName on the ML or equivalent document matchesIOR identified on current Form FDA 1572 or IORFormMedical License (ML)The ML or equivalent document is current (notexpired). Note that if the ML does not designate anexpiration date, it can be accepted.Curriculum Vitae (CV) andMedical LicenseEffectiveD. IRB/EC/Regulatory Entity(ies)/Regulatory Authority(ies) documentationReview RequirementDetailed RequirementsComplete protocol title or short title for the currentDAIDS approved version of the protocol.IRB/EC ApprovalsDAIDS-ES and/or Network Protocol IDDAIDS Protocol Version Number from the finalversion of the protocol approved by DAIDS and/orthe final version date of the proto
The DAIDS Protocol Registration Manual is a reference tool to help CRSs successfully complete the DAIDS protocol registration process. This manual explains the different types of protocol registration submissions as well as a list of the required documents for each type of submission.
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