The Mindich Child Health and Development Institute

The objective of the Pediatric Clinical Trials Office is to provide research infrastructure for the process of moving projects from initial proposal through contract execution/internal review board approval. This includes review and execution of confidentiality disclosure agreements, cost and feasibility analysis, budget development and contract execution. In addition, this office provides ongoing financial, regulatory, and study oversight for all clinical trials.

The Pediatric Clinical Trials Office consists of 4 specialized teams: Regulatory Compliance, Financial Management, Clinical Coordination, and Research Operation Teams.

Regulatory Compliance

The Regulatory Compliance team of the PCTO provides regulatory services that include:

• Site Qualification Visits

• All IRB Submissions which includes:

  • Completing the internal and external appropriate paperwork

  • Preparation of the Informed Consent Forms

  • Submitting new PPHS (IRB) applications

  • Continuation Reports

  • Revisions and Amendments

  • Final reports

  • Protocol deviations

  • Serious adverse events

  • Advertising/ recruitment materials

• Submitting the initial regulatory packet to the sponsor, this includes, but is not limited to the following:

  • 1572 form

  • CV's and licenses for the Principal Investigator and all team members assigned to study

  • Preparation and Maintenance for electronic Regulatory Binder

  • Other sponsor specific regulatory requests

Once a study has begun the team is responsible for ongoing maintenance and compliance with the federal, state, and institutional regulatory requirements. They work closely with study sponsors to maintain the regulatory e-binder and handle all regulatory requests throughout the course of the study.

Business Operations

The Business Operations team provides financial services that include:

• Completing the appropriate paperwork

• Coordination of Confidentiality Agreements

• Budget Analysis

• Study budget preparation and negotiations

• Facilitate Contract Negotiations with institutional policies

• Grant start-up (opening a grant)

• Ongoing management of the study grant with Sponsored Projects, Division Administrators & DOM

• Monthly Invoicing to the sponsor

• Facilitate and Contract Amendments as they arise during the course of a study

• Monitoring of grant expenses 

• Patient care costs 

• Payments for ancillary services performed during the study 

• Check requests for patient stipends, etc.

Clinical Coordination

The Clinical Coordination team assists the investigators by providing accuracy and compliance for current clinical studies. The Clinical Research Coordinators and Clinical Research/Trial Managers work closely with the investigators in confirming eligibility requirements for patients, educating patients about protocol requirements, following patients on study protocols, and completing precise data collection and entry. Additional responsibilities include:

• Preparation of any Pre-Site Selection Surveys with Investigators

• Facilitate Site Qualification Visits

• Working with regulatory for Site Readiness

• Attending investigator meeting(s)

• Preparing for study initiation

• Assisting investigators with recruitment of subjects

• Screening and scheduling subjects

• If delegated, ensure proper Informed Consent Documentation and Process

• Ensuring subjects understand protocol expectations

• Performing study/protocol procedures in a detailed, accurate manner

• Entering subject data and responding to data queries

• Maintaining study and regulatory files

• Tracking subjects and maintaining communication to reduce loss-to-follow-up

• Documenting adverse and serious adverse event(s)

Research Operations

The Research Operations team handles the various behind-the-scenes steps to properly activate and manage ongoing research studies. General responsibilities include, but are not limited to, the following:

• Collection of legal, financial, and regulatory documentation to create complete “Protocol Package”

• Dissemination of pertinent documentation to all required reviewing entities (i.e. FACTS Office, IT Security Review, etc.)

• Building of study source documentation into Mount Sinai databases

• Entry and management of study and subject information into the Mount Sinai Clinical Trial Management System (CTMS)

• Discussion, development, and management of Investigator-Initiated-Trials

Our services encompass assisting researchers in the Department of Pediatrics with a wide range of tasks, including:

• Protocol feasibility determination in collaboration with investigators and senior leadership
• Negotiating study budgets and contracts with sponsors
• Providing financial management throughout the lifecycle of the study
• Collaboration with sponsors and/or contract research organizations to prepare all pre-award documentation, including regulatory submissions
• Centralized processes and resources through four core teams: Regulatory Compliance, Financial Management, Clinical Coordination, and Research Operations
• Investigator-initiated trial development, activation, and management
• Overseeing coordinator activities, including onboarding, cross-training, and mentoring

Interested in collaborating with us? Contact us today to learn how we can support your research efforts and contribute to advancing pediatric healthcare.

The PCTO staff have successfully implemented and coordinated many large, multi-centered clinical trials. The PCTO supports investigators conducting trials in numerous therapeutic areas as noted below:

• Allergy & Immunology
• Cardiology
• Device Trials               
• Endocrinology                                                 
• Gastroenterology
• Infectious Diseases
• Nephrology
• Neonatal ICU
• Pediatric ICU

The site is well equipped to perform Phase 1 through Phase 4 studies, first-in-human PK and PD protocols.

Diagnostic/Clinic Equipment (regularly calibrated)

• Vital Sign Equipment (BP, Temperature, Respiratory Rate, Pulse Oxygen)

• Analog and digital weight scales

• ECG machines

• Lab drawing and processing equipment

• Centrifuges (Ambient & Refrigerated)

• Freezers (0, -20, and -80 degree Celsius)

• Access to Dry Ice

• Extended stay capability-infusion rooms