Boston Children’s Hospital is committed to advancing pediatric care through strong collaboration with research sponsors. To ensure a smooth and efficient study start - up process, we would like to outline our key guidelines and expectations when working together.
Study start-up timelines
Boston Children's Hospital is actively working to improve study turnaround times. Please note that our internal timelines begin upon receipt of a complete start - up package. This includes, at minimum:
- Protocol and investigator brochure
- All patient-facing materials
- Pharmacy and laboratory manuals
- Safety Data Sheets (SDS) for study drugs or devices or equivalent information sheet for hazardous assessment
- Any other materials outlined in the Boston Children's Hospital Site Qualification Information Document
Incomplete packages may delay processing, so we strongly recommend submitting all documents simultaneously.
Regulatory Management at Boston Children's
Boston Children's Hospital uses the Advarra eRegulatory (eReg) Management System for regulatory oversight of clinical research. This includes the electronic Delegation of Authority (eDoA) log, which is our institutional standard for tracking investigator responsibilities and study team qualifications. While sponsors may use different nomenclature, the Boston Children's eDoA includes all standard research tasks and corresponding equivalents.
Using eReg and eDoA enhances efficiency by centralizing and maintaining CVs, licenses, and training records for all study team members, which reduces regulatory maintenance time.
Monitoring visits
Remote regulatory monitoring is preferred whenever feasible. If on-site monitoring is required, monitors will be classified under Boston Children's Hospital policy as either:
- Associated Personnel (AP): For monitors accessing patient-facing areas. APs require badge access and Boston Children's Hospital system credentials.
- Short-term Non-Clinical Visitors: For monitors not entering patient-facing areas. These individuals must be escorted by Boston Children's Hospital staff at all times.
Please schedule on-site visits well in advance to allow for the completion of necessary forms, communications, and access requests.
Communication and Escalation
To streamline communication and support timely resolution of any issues, we ask that each sponsor designate a single point of contact for coordination with Boston Children's Hospital. We look forward to a productive collaboration. For any research-related inquiries, please reach out to: bch.cro.help@childrens.harvard.edu