The following services are available through the Pediatrics Center for Research Advancement. For requesting services, please complete the online .
Assistance with:
BRAIN and Affiliate Hospital IRB applications - new, amended and annual renewal submissions and AE/SAE reporting
Informed consent development and translation
Development of Data Safety Monitoring Plan and implementation
Investigational New Drug (IND) and Investigation Device Exemption (IDE) submissions
Certificate of Confidentiality submissions
Required reporting to clinical trials databases (e.g., clinicaltrials.gov)
Liaise with federal agencies and pharmaceutical sponsors
Create and maintain electronic master regulatory files for each protocol
Electronic maintenance and distribution of protocols and consent forms
Storage of research records
Administrative coordination with outside sponsors and investigators
Oversight and coordination of external audit preparations
Conduct internal patient and regulatory audits
Identify issues and needs in research procedures; develop and implement SOPs
Train clinical research personnel in proper procedures, documentation, and reporting
Screen, verify, consent and register study participants
Administration of investigational agents, questionnaires, etc.
Ordering and facilitating the completion of all study required tests and procedures
Ensure patient safety, follow-up and continuity of care during study participation
Capture of all data through source documentation and proper recordkeeping, and completion of case report forms (paper and/or electronic)
Evaluation and reporting of adverse events in collaboration with the study specific regulatory staff
Maintain research charts containing relevant documents for each trial patient
Assure compliance with protocol requirements with emphasis on safety, protection of human subject and high ethical standards
Proper consenting of patients including protection of patient’s rights and autonomy
Maintain ongoing communication with the PI and amongst investigators, clinic nurses, investigational pharmacy, radiology, laboratory, etc. and with external sponsors
Experimental design and data analyses
Subject Randomization design
Abstract, manuscript and preparation (statistical plan)
Study design recommendations for retrospective and prospective research efforts
Sample size considerations
Traditional and advanced statistical methods for data analyses
Graphical displays for summarizing data
Development of study-specific databases including randomization and electronic case report forms (eCRFs)
Maintenance of database of protocols, patient registry and clinical data
Entry of clinical and translational data into the database
Development of reports for study staff, sponsors, and Data Safety Monitoring Boards
Monitoring and reporting of accrual, including tracking of minority recruitment
Preparation / distribution of open trials list to investigators and hospital committees
Design and development of auxiliary tools and systems to automate workflow and processes
Assist investigators with developing grant budgets
Assist with grant application and progress report submissions in BRAIN and sponsor agency systems
Program Project or Center Grant application coordination support
Clinical trial budget development and negotiation with sponsors
Facilitate contract review processing in coordination with the Office of Research
Assist faculty with time and effort certification
Assist faculty with post award administration, including financial reconciliation, financial reporting and sub-award processing
Study drug procurement, storage, dispensing, compounding, and inventory maintenance
Study initiation coordination and development of drug information sheets
Inventory maintenance of study drug
Study drug compounding of special formulations (parental, oral, etc.), if required
Study drug dispensing, labeling and accountability documentation