QIP Services

At the time of study start-up or throughout the life of a protocol, QIP is available to meet with the research team to help anticipate and resolve regulatory issues that may hinder the IRB review and approval process.

To facilitate the IRB review and approval process, QIP is available to aid in drafting or to pre-review IRB submissions, assist with navigation and submission through ESTR, or help respond to questions posed by the IRB.

At the request of the Principal Investigator or study staff member, QIP is available to conduct both domestic and international onsite review of study documentation to ensure regulatory compliance including protocol adherence, accurate record keeping, and appropriate informed consent process. During the onsite review, QIP will provide corrective actions and offer quality improvement recommendations.

Each academic year, QIP offers a different education series with sessions focusing on various topics including IRB submission requirements, study management, and informed consent process. Those who attend 3 sessions during an academic year will receive Human Research training refresher credit. Check out the current Education Series schedule and past presentation slides.

Upon request, QIP staff is available to conduct any size group training sessions on a variety of topics relating to research compliance; institutional and school policy; Good Clinical Practice; Exemptions; Informed Consent; Regulatory Documentation, etc. These sessions are developed to meet the specific needs of the study site. Depending on the depth and length of the in-service, attendees may earn Human Research training credit for their participation.

Upon request, QIP is available to meet with new study staff (PIs, Coordinators, etc.) in order to familiarize them with ORARC policies and procedures including the IRB review and approval process. Participants will learn about available human research support services and study management tools.

QIP offers a variety of easy-to-use study management tool templates to assist research sites in maintaining and organizing essential study documents. These tools can be downloaded and tailored to your specific study needs. Submit your request for a new tool to qip@hsph.harvard.edu. If you would like for QIP to customize one of our existing tools to fit your study needs complete a Service Request Form.

Enlist the QIP staff to review and edit the language that you have drafted for the human subjects sections of your grant application study records to ensure that they properly identify and address all the necessary human subjects concerns.

Obtain temporary floating research coordinator/project manager support for assistance in the implementation of HLC IRB-approved protocols at no cost. Research Coordinators/Project Managers are Certified IRB Professionals who have an in-depth understanding of both institutional policies and federal regulations. They are available to provide short or long-term coverage for a variety of research related services, including recruitment, obtaining consent, and study management.

This service is subject to availability of QIP Staff for the specified amount of time.

The services incorporated into the PASS Initiative are an opportunity for QIP to provide additional catered education and resources to help researchers establish and maintain good study conduct and regulatory compliance after IRB approval is received.

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