Investigator Forms

Initial Study Submission Guidelines

The staff at Liberty IRB, Inc. is happy to assist you with the application process. To provide you with the shortest document turn around, it is essential that all forms are completed as indicated. All forms may be completed online and printed, or printed and completed manually. Upon receipt of your submitted materials, you will be contacted by a project manager who will keep you informed about the processing of your documents.

Adobe Acrobat is required to view our forms. Click here to download:

SubmissionChecklist.pdf  SubmissionChecklist.doc  Investigator Submission Checklist

SubmissionChecklist.pdf  SubmissionChecklist.doc  Sponsor Submission Checklist

SampleSubmissionLetter.pdf  SampleSubmissionLetter.doc  Sample Submission Letter

additional_research_location.pdf  additional_research_location.xls  Additional Research Location Form

PIInfoSponsorBilling2003.pdf  PIInfoSponsorBilling2003.doc  Principal Investigator Information Form

InvestigatorDeclaration.pdf  InvestigatorDeclaration.doc  Investigator Declaration

LibertyIRBSampleConsent.pdf  LibertyIRBSampleConsent.doc  Sample Informed Consent

AdvertisementSubmissionForm.pdf  AdvertisementSubmissionForm.doc  Advertisement Submission Form

protocol_information.pdf  protocol_information.xls  Protocol Information Sheet

LibertyTranslationForm.pdf  LibertyTranslationForm.doc  Translation Form

    Billing Information Sheet

    Modifications to Research (Protocol, IB, Consent)          

    Modifications to Research (PI, Sub-Investigator, Coordinator)

    Modifications to Research (Other Documents)

 

California Bill of Rights [English

California Bill of Rights [Spanish]
 

HIPAAauthorizationForm.pdf  HIPAAauthorizationForm.doc  HIPAA Authorization Form

    Liberty Authorization Agreement

     Request for Determination of Exemption
     Request for Waiver of Informed Consent
     Request Waiver of Written Documentation of Consent

The following three criteria must be satisfied for the IRB to approve a waiver of authorization under the Privacy Rule:
1. The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
     *  an adequate plan to protect the identifiers from improper use and disclosure;
     *  an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research,    unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
     *  adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart;
2. The research could not practicably be conducted without the waiver or alteration; and
3. The research could not practicably be conducted without access to and use of the protected health information.
 

    Request for Waiver of Authorization

Continuing Review / Study Closure

Sites will be notified one to two months prior to study approval expiration date. You will be requested to complete a continuing review form and submit a copy of your current consent.

    Continuing Review Form

    Closure Form

    Special Laboratory Testing Consent

    Research Site Specific Consents, Advertisements and Documents

Reportable Events

Liberty IRB requires Investigators to report within 5 working days any changes significantly affecting the conduct of the research or that increase the risk to participants, including any of the following using the Reporting Form.
·        Internal adverse events which are unexpected and related to the research;
·        External adverse events which are unanticipated problems involving risks to participants and others, as determined by the study investigator;
·        Changes made to the research without prior IRB approval in order to eliminate apparent immediate harm;
·        Other unanticipated information that indicates participants or others might be at increased risk of harm such as a new risk, identified in an interim safety analysis, revised package insert, revised investigator brochure, publication in the literature or a DSMB report.
·        Unanticipated problems involving risks to participants or others will be defined as any report of information that is (1) unanticipated and (2) indicates that participants or others are at increased risk of harm;
·        Allegation or finding of non-compliance;
·        Major protocol deviations or violations that might affect the rights safety and welfare of subjects;
·        Termination or suspension of the clinical trial by the study sponsor;

·        Unanticipated, serious adverse drug or device effects 

Initial notification is requested within 5 business days of discovery. Initial notification should include any details surrounding the event which are available. Follow up completion of the Reporting form is required within 10 days of discovery.

What SAEs are unanticipated problems and need to be reported to the IRB?

        

                Reporting Form

Institution Forms

sample_release_letter.pdf  sample_release_letter.doc Sample Hospital/ University Release Letter

libertyIRB_authorization_agreement.pdf  libertyIRB_authorization_agreement.doc  Liberty IRB Authorization Agreement

Send all materials to our new location:

Chesapeake IRB
6940 Columbia Gateway Drive
Suite 110
Columbia, MD 21046
Phone: 410-884-2900
Fax: 410-884-9190