Forms

FORM ID

NAME OF FORM

USE WHEN SUBMITTING

ADDITIONAL INFORMATION

MLH IRB Form 001
(Revised 04/19/10)

Protocol Submission Form

• New research studies
• Any submissions to ORA (except with Continuing Review/Final Reports)

MLH IRB Form 002(Revised 04/19/10)

Initial Submission Form

• New research studies

MLH IRB Form 003
(Revised 04/19/10)

Continuing Review/Final Report Form

• Renewal for an ongoing study
• Final Report/Termination

• Renewals should be submitted a minimum of 6-8 weeks before expiration date of study. IRB approval must be maintained in order to conduct research.
• Final Report/Termination requests must be submitted when all research activities are completed and must include a summary of the research activities.

MLH IRB Form 004A

Unanticipated Problems Reporting for SAEs/UADEs

• An anticipated problem in a study which is a Serious Adverse Event or Unanticipated Adverse Device Effect

• Flow Chart for Determining Which Adverse Events ARE Unanticipated Problems that must be reported to the IRB.
• Information Sheet for Reporting Unanticipated Problems that ARE Serious Adverse Events or Unanticipated Adverse Device Effects

MLH IRB Form 004B

Unanticipated Problems Reporting for NON-SAEs/UADEs

• An anticipated problem in a study which is NOT a Serious Adverse Event or Unanticipated Adverse Device Effect

• Flow Chart for Determining Which Adverse Events ARE Unanticipated Problems that must be reported to the IRB.
• Information Sheet for Reporting Unanticipated Problems that ARE NOT Serious Adverse Events or Unanticipated Adverse Device Effects

MLH IRB Form 005

Grant Application Information Form

• A new grant or a change in an existing grant

Should be submitted with all grant funded research at time of new study submission or whenever a grant is awarded or changed

MLH IRB Form 006
(Revised 04/19/10)

HIPAA Authorization Form

• New research studies involving the use of protected health information (PHI)

HIPAA Revocation Form

N/A

Use when a currently enrolled research subject wishes to withdraw their consent for use of their protected health information from a study

Form B

Conflict of Interest Form "B" for Investigators

• New research studies
• Annual renewal for an ongoing study

Required by all personnel involved in the conduct of the study

Budget(Revised 12/9/09)

Clinical Trial Budget Submission Template

• New research studies

Use with ALL study types (funded and un-funded)

MLH New Research Proposal Transmittal Form

• New research studies

Use with all study types (funded or un-funded). ORA will not accept a new study without all required signatures

• Information Sheet for MLH Transmittal Form (Revised 06/19/10)