CHS Forms and Templates

Protocol Application - Form that needs to be completed when submitting a new study for review by the CHS

Protocol Application for Medical Record/Discarded Tissue/Samples Studies - Form that needs to be completed when submitting a new study only involving the use of medical record information and/or discarded tissue/samples for review by the CHS

Consent & HIPAA Authorization Form Template - Current format for the consent & HIPAA authorization form that needs to be used when obtaining informed consent/authorization for the use of PHI from subjects to participate in research

Assent Form Template - Current format for the assent form that needs to be used when obtaining assent from children (<18 years old) to participate in research

Request to Add New Members to Study Team - Form that needs to be completed to add a new member to an approved study's team

Adverse Event Reporting Form - Form that needs to be completed when reporting an adverse event to the CHS

Protocol/Informed Consent Violation/Deviation Reporting Form - Form that needs to be completed when reporting a protocol and/or informed consent violation/deviation to the CHS

Partial Waiver of Authorization to Contact Potential Research Subjects - Form that needs to be completed to request a partial waiver of authorization to access PHI to contact potential research subjects

Partial Waiver of Authorization to Identify Potential Research Subjects - Form that needs to be completed to request a partial waiver of authorization to access PHI to identify potential research subjects

Progress Report/Termination Notice Form - Form that needs to be completed when submitting a progress report or termination notice to the CHS for a previously approved research study

Progress Report/Termination Notice Form for Medical Record/Discarded Tissue/Samples Studies - Form that needs to be completed when submitting a progress report or termination notice  to the CHS for a previously approved research study only involving the use of medical record information and/or discarded tissue/samples

Human Subject Research Determination Form - Form that needs to be completed and submitted to the CHS so a determination can be made if an activity constitutes human subject research

PI Qualifications Form - For that should be used by an Investigator to determine if it is acceptable for them to be the Principal Investigator on a human subject research study at Joslin