The following services are available through the Pediatrics Center for Research Advancement. For requesting services, please complete the online Consultation/Service Request and TCH Investigational Pharmacy Services Form.
- 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
- Instructions for accessing the Texas Children's Hospital (TCH) Investigational Pharmacy Services Request for Consultation/Service Form