Post-Approval

Below is a summary of the process for an investigator initiated prospective interventional study. Please note that the process is different (in terms of the order of events and the investigator responsibilities) for studies for which the principal investigator is not the sponsor (such as in cases when s/he serves as the principal investigator for one site of a multi-site study sponsored by a pharmaceutical company).

The process is also different for studies that don’t involve drugs or devices, such as behavioral studies. For example, in those cases, the FDA would not need to be involved.

Please be advised that some documentation will need to be maintained in the eRegulatory System, while other documentation will be maintained in a separate regulatory binder. The documents utilized may also differ per protocol.

After IRB Review and Approval:

• Register in clinicaltrials.gov and enter follow up information within one year of study completion.
• Site activation and enrollment
  • Site Initiation Visit
  • Training and Delegation logs
  • Prepare for Screening and Enrollment
  • Pharmacy
  • Recruitment and enrollment
  • Regulatory and data activities
    • Data collection and review
      • Electronic Health Records (EHRS) (as applicable)
      • Completed surveys (as applicable)
    • Laboratory and specimen collection and review (as applicable)
    • Completion of case report forms (CRFs)
    • Drug/device management
    • Identification and reporting of reportable events (as applicable)
• Trial closure

Access to the following programs:

• eResearch (link for more information here)
• eRegulatory System Resources (link for more information here)
• OnCore Resources (link for more information here)

Applications to the following program (as applicable) before enrolling:

• Clinicaltrials.gov

*It is required to submit with the support of the Office of Research Administration. More information about the process and whom to contact is available here.

Study Documents

• Protocol (your most recent version should be stored in eResearch)
• Informed Consent Form (your most recent version should be stored in eResearch)
• Case Report Form (CRF) (typically developed by the study team)

Study Staff Documents

• Staff resumes/CVs (provided by study team)
• Staff medical licensure (if applicable) (provided by study team)
• Financial disclosures (completed via eResearch)

IRB Documents

• Statics Documentation (documentation that is typically established/completed once and does not require changes/updates over time)
  • Submission (provided by the IRB)
    • Initial approval
    • Amendments
    • Study renewal
    • Safety information/acknowledgment
    • Final study closeout
  • Membership roster (provided by the IRB)
  • Sponsor correspondence
  • Approval letters

FDA Documents

Contact iirp@hmhn.org for support in this process.

• Submit annual review
• Submit any reportable events
• Submit any amendments made to the study (including changing sub-I or PI)
• Upon completion, withdraw IND or close IDE.

Logs

• Training Log (templates available through the ORA)
• Delegation of Authority Log (templates available through the ORA)
• Eligibility (typically developed by the study team)
• ICF Tracking (templates available through the ORA)
• Enrollment (templates available through the ORA)
• Temperature log (need to document temperatures on study drugs at least twice a day. The nature of the tracking system may be protocol specific)

Patient Facing Materials

• Advertisements such as posters/flyers or brochures (templates for flyers are available through the HMH Brand Center)

Labs

• Clinical laboratory certifications
• Laboratory reference ranges
• Biospecimen handling procedures

Shipping

• Review of shipping instructions (protocol specific - for medialab training contact Anne Detoro - Anne.Detoro@hmh.org)
• Handling instructions (protocol specific - for medialab training contact Anne Detoro - Anne.Detoro@hmh.org)
• Shipping and packing records (protocol specific - for medialab training contact Anne Detoro - Anne.Detoro@hmh.org)

Drug Management

• Investigational drug brochure (IDB)
• Decoding procedures
• Drug accountability forms and supply inventory logs

Reportable Events

• IND Safety Reports
• Serious Adverse Events (SAE) Report
• Violation/Deviation Report
• Reportable New Information (RNI) Report (completed via eResearch)

*Here are reasons for which an RNI would be submitted.

• Compliance Hotline

Audits

Researchers can request internal audits on their studies and will be subject to internal or external audits. For more information about auditing and monitoring, contact Martin.Kleber@hmhn.org.

• Audit Report

Authorship

Please note that who will be included in the authorship list and where the study will be published should be considered early on in the process.

• The HMHN Libraries can assist with the selection of a journal and subsequent submission.
  • Accessing the HMH Library Off-Campus
  • Accessing the HMH Library On-Campus

Post-Award

• Contact postaward@hmhn.org

Below is a summary of the process for an investigator initiated prospective observational study. This research design identifies a group of participants and follows them forward in time to observe outcomes as they naturally occur. Furthermore, there is no assignment to or manipulation of exposures or treatments. Examples include review of medical records ‘forward’ in time and administered surveys.

Please be advised that some documentation will need to be maintained in the eRegulatory System, while other documentation will be maintained in a separate regulatory binder. The documents utilized may also differ per protocol

After IRB Review and Approval:

• Study activation and enrollment
  • Training and Delegation logs
  • Prepare for Screening and Enrollment
  • ICF Tracking
  • Recruitment and enrollment
  • Regulatory and data activities
    • Data collection and review
      • Electronic Health Records (EHRS) (as applicable)
      • Completed surveys (as applicable)
    • Laboratory and specimen collection and review (as applicable)
    • Completion of case report forms (CRFs)
    • Identification and reporting of reportable events (as applicable)
• Study closure

Access to the following programs:

• eResearch (link for more information here)
• eRegulatory System Resources (link for more information here)
• OnCore Resources (link for more information here) (not applicable if the study does not have a budget or a Medicare Coverage Analysis)

Study Documents

• Protocol (your most recent version should be stored in eResearch)
• Informed Consent Form (your most recent version should be stored in eResearch)
• Case Report Form (CRF) (typically developed by the study team)

Study Staff Documents

• Staff resumes/CVs (provided by study team)
• Staff medical licensure (if applicable and provided by study team)
• Financial disclosures (completed via eResearch by each member of the study team)

IRB Documents

• Statics Documentation (documentation that is typically established/completed once and does not require changes/updates over time)
  • Submission (provided by the IRB)
    • Initial approval
    • Amendments
    • Study renewal
    • Final study closeout
  • Membership roster (provided by the IRB)

Logs

• Training Log (templates available through the ORA)
• Delegation of Authority Log (templates available through the ORA)
• Eligibility (typically developed by the study team)
• ICF Tracking (templates available through the ORA)
• Enrollment (templates available through the ORA)
• Temperature log (need to document temperatures on study drugs at least twice a day. The nature of the tracking system may be protocol specific)

Patient Facing Materials

• Advertisements such as posters/flyers or brochures (templates for flyers are available through the HMH Brand Center)

Labs

• Clinical laboratory certifications
• Laboratory reference ranges
• Biospecimen handling procedures

Shipping

• Review of shipping instructions (protocol specific - for medialab training contact Anne Detoro - Anne.Detoro@hmh.org)
• Handling instructions (protocol specific - for medialab training contact Anne Detoro - Anne.Detoro@hmh.org)
• Shipping and packing records(protocol specific - for medialab training contact Anne Detoro - Anne.Detoro@hmh.org)

Reportable Events

• Dynamic Documentation (documentation that may require changes/updates over time)
  • Reportable New Information (RNI) Report (completed via eResearch)
• Compliance Hotline (link here)
• Violation/Deviation Report (templates available via the ORA)

*Here are reasons for which an RNI would be submitted.

Audits

Researchers can request internal audits on their studies and will be subject to internal or external audits. For more information about auditing and monitoring, contact Martin.Kleber@hmhn.org.

• Audit Report

Authorship

Please note that who will be included in the authorship list and where the study will be published should be considered early on in the process.

• The HMHN Libraries can assist with the selection of a journal and subsequent submission.
  • Accessing the HMH Library Off-Campus
  • Accessing the HMH Library On-Campus

Post-Award

• Contact postaward@hmhn.org

Below is a summary of the process for an investigator initiated retrospective study. Investigators utilizing this study design look backward in time to examine existing data or past records to identify exposures and outcomes that have already occurred. All data have already been collected prior to the start of the study. An example of a retrospective study would be a chart review and/or review of medical records for a given population.

Please be advised that some documentation will need to be maintained in the eRegulatory System, while other documentation will be maintained in a separate regulatory binder. The documents utilized may also differ per protocol.

After IRB Review and Approval:

• Study activation and enrollment
  • Training and Delegation logs
  • Prepare for Screening and Enrollment
  • Recruitment and enrollment
  • Regulatory and data activities
    • Data collection and review
      • Electronic Health Records (EHRS)
    • Identification and reporting of reportable events (as applicable)
• Study closure

Access to the following programs:

• eResearch (link for more information here)
• OnCore Resources (link for more information here) (not applicable if the study does not have a budget or a Medicare Coverage Analysis)

Study Documents

• Protocol (your most recent version should be stored in eResearch)
• Case Report Form (CRF) (typically developed by the study team)

Study Staff Documents

• Staff resumes/CVs (provided by the study team)
• Staff medical licensure (if applicable) (provided by the study team)
• Financial disclosures (completed via eResearch)

IRB Documents

• Submission (provided by the IRB)
  • Initial approval
  • Amendments
  • Study renewal
  • Final study closeout
• Membership roster (provided by the IRB)

Data Requests

• Research Data Platform
  • For aggregated data at a glance
• Service Now Ticket Request
  • Utilize ‘MySupport’ to request patient level data for research that accesses the ‘backend’ of Epic data

Logs

• Training Log (templates available through the ORA)
• Delegation of Authority Log (templates available through the ORA)
• Eligibility (typically developed by the study team)

Reportable Events

• Violation/Deviation Report (typically developed by the study team)
• Reportable New Information (RNI) Report (completed via eResearch)

*Here are reasons for which an RNI would be submitted.

• Compliance Hotline (link here)

Audits

Researchers can request internal audits on their studies and will be subject to internal or external audits. For more information about auditing and monitoring, contact Martin.Kleber@hmhn.org.

• Audit Report

Authorship

Please note that who will be included in the authorship list and where the study will be published should be considered early on in the process.

• The HMHN Libraries can assist with the selection of a journal and subsequent submission.
  • Accessing the HMH Library Off-Campus
  • Accessing the HMH Library On-Campus