1 2 3 4 5 6 7 8 9 10 0% Complete 1 of 10 Contact Information Site Name * Point of Contact First Name Last Name Title/Role Degree(s) Address Address Line 2 City State Zip Code Email Phone Physician Site Champion First Name Last Name Title/Role Degree(s) Address
Address Line 2 City State Zip Code Email Phone Point of contact (if different from the person filling out the form) First Name (Point of Contact) Last Name (Point of Contact) Email Phone Required Files Organizational Chart for your clinical research team * Drop a file here or click to upload Maximum upload size: 134.22MB CV of Physician Site Champion * Drop a file here or click to upload Maximum upload size: 134.22MB Copies of any 483's in the past 2 years (if applicable) Drop a file here or click to upload Maximum upload size: 134.22MB
10% Complete Section 1: General Information Number of pediatric inpatient beds at your Institute Total number of annual pediatric outpatient visits Please identify any and all pediatric subspecialties you HAVE at your institute Adolescent Medicine Allergy / Immunology Ambulatory Pediatrics Anesthesiology Behavioral Pediatrics Cardiology Child Abuse Community Based Pediatric O ces Community Based Urgent Care Critical Care Dermatology Emergency Medicine Endocrinology Gastroenterology Genetics Hematology/Oncology Infectious Disease Neonatology (NICU) Nephrology Neurology Orthopedics Pain Management Pathology Pharmacology / Toxicology Psychiatry Psychology Pulmonary Radiology Rheumatology Sports Medicine Surgery Please list any any additional areas you HAVE at your Institute Pick either "States" or "Counties" to best describe the size of your catchment area States Counties Number of States
7/9/2018 Contact I-ACT for Children What percentage of each category makes up the population your institute provides care for: a. American Indian or Alaskan Native b. Asian c. Black or African American d. Native Hawaiian or Paci c Islander e. White f. Hispanic/Latino Are you a birthing hospital/facility, but a liated with/access to a birthing facility Is your Institution part of a Clinical and Translational Science Award Please check the consortium/pediatric research groups your institution is currently working with (if any): Childhood Arthritis and Rheumatology Research Alliance (CARRA) Childhood Liver Disease Research Network (ChiLDREN) Children s Oncology Group (COG) COG Developmental Therapeutics Consortium Cystic Fibrosis Therapeutic Development Network (TDN) ImproveCarew International Study Group of Pediatric Pancreatitis (INSPPIRE) Midwest Pediatric Nephrology Consortium National Experimental Therapeutics Consortium (NEXT Consortium) rth American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) A National Pediatric Learning Health System (PEDSnet) Pediatric Acute Lung Injury & Sepsis Investigators (PALISI) Pediatric Blood and Marrow Transplant Consortium (PBMTC) Pediatric Critical Care Blood Research Network (BloodNet) Pediatric Heart Network (PHN) Pediatric In ammatory Bowel Disease (PIBD) Collaborative Research Group Pediatric Neuro-Oncology Consortium (PNOC) Pediatric Rheumatology Collaborative Study Group (PRCSG) Pediatric Trials Network TrialNet Does your site have an established parent/child advocacy or engagement group with knowledge or experience in pediatric clinical trials? It is a work in progress Previous Next
20% Complete Section 2: Satellite Site Information Does your Institution have satellite sites where clinical trials are being conducted? How many satellite sites? What clinical services are the satellites? (e.g. outpatient surgery, outpatient clinics, radiology, pharmacy, laboratory, etc.) Are the satellites equipped and capable to enroll, screen, and treat subjects on pediatric clinical trials? If no, please explain Previous Next https://www.iactc.org/site/wp-admin/admin-ajax.php?action=frm_forms_preview&form=5yta6&theme=1 1/2
30% Complete Section 3: Contract, IRB & Review Information Does your site currently use Master Clinical Trial Agreements (MCTAs)? Please list all sponsors who they are with: Does your site require a fully executed contract prior to IRB submission? What is the average turnaround time for a fully executed contract for a pediatric IND/IDE study (from the date you receive the contract to all parties have signed)? What type of IRB does your site use? Institutional IRB ONLY Central IRB ONLY Institutional, Reliance and Central IRBs - depends on the study Would your Institution be willing to use a central IRB for studies conducted through I-ACT for Children, if there was adequate pediatric experience Does your Institution have a Scienti c Review Committee For select types of protocols, please specify What is the average turnaround time for the Scienti c Review Committee? 1 week 2 weeks More than 2 weeks
If your Institution has other committees that must review industry sponsored clinical trials before they can be approved by the IRB, what is the average turnaround time? 1 week 2 weeks More than 2 weeks Previous Next
40% Complete Section 4: Clinical Trial Experience Information 1. Please identify any and all areas in which your site conducts clinical trials by checking the box to the left, next to the sub-specialty Adolescent Medicine Hematology/Oncology Radiology Birth Control Infectious Disease Rheumatology Eating Disorders Anti-Viral/Anti-Fungal JRA Substance Abuse Vaccine Sports Medicine Ambulatory Pediatrics RSV Surgery Anesthesiology Antibiotic/Infections Post Op Pain Management Allergy/Immunology Behavioral Pediatrics Neonatology (NICU) ADHD/ODD Prematurity Downs Syndrome Feeding Disorders Cardiology Nephrology Pulmonary Hypertension Hypertension Device Research Nephrotic Syndrome Child Abuse Osteogenesis Imperfecta Community Pediatric O ces Neurology Community Urgent Care Migraines Critical Care Epilepsy Dermatology Multiple Sclerosis Eczema Neuromuscular Disorders Acne Pathology Emergency Medicine Pharmacology/Toxicology Endocrinology PK/PD Studies Type 1 Diabetes Psychiatry Type 2 Diabetes Mood Disorders Growth Hormone Def. Anxiety Disorders Gastroenterology Schizophrenia Irritable Bowel Syndrome Psychology Crohn s Disease Pulmonary Celiac Disease Cystic Fibrosis Genetics Asthma Subspecialty Areas: Sub-specialties We would like to obtain performance data about the 5 key areas you identi ed as your site s research strengths. We are speci cally looking for information related to your site s experience with clinical trials conducted under an Investigational New Drug Application (IND) with the FDA. Sub-specialty 1:
In the past year, how many studies were conducted in this sub-specialty? # of Investigator Initiated Observational Studies in this sub-specialty # of Investigator Initiated Therapeutic Studies (Phase I - III) in this sub-specialty # of Investigator Initiated Device Studies in this sub-specialty # of Industry Sponsored Trials in this sub-specialty # of Industry Sponsored Device Trials in this sub-specialty Target # of subject to be enrolled Actual # of subjects enrolled Sub-specialty 2 Sub-specialty 2: In the past year, how many studies were conducted in this sub-specialty? # of Investigator Initiated Observational Studies in this sub-specialty # of Investigator Initiated Therapeutic Studies (Phase I - III) in this sub-specialty # of Investigator Initiated Device Studies in this sub-specialty # of Industry Sponsored Trials in this sub-specialty # of Industry Sponsored Device Trials in this sub-specialty Target # of subject to be enrolled Actual # of subjects enrolled Sub-specialty 3 Sub-specialty 3:
In the past year, how many studies were conducted in this sub-specialty? # of Investigator Initiated Observational Studies in this sub-specialty # of Investigator Initiated Therapeutic Studies (Phase I - III) in this sub-specialty # of Investigator Initiated Device Studies in this sub-specialty # of Industry Sponsored Trials in this sub-specialty # of Industry Sponsored Device Trials in this sub-specialty Target # of subject to be enrolled Actual # of subjects enrolled Sub-specialty 4 Sub-specialty 4: In the past year, how many studies were conducted in this sub-specialty? # of Investigator Initiated Observational Studies in this sub-specialty # of Investigator Initiated Therapeutic Studies (Phase I - III) in this sub-specialty # of Investigator Initiated Device Studies in this sub-specialty # of Industry Sponsored Trials in this sub-specialty # of Industry Sponsored Device Trials in this sub-specialty Target # of subject to be enrolled Actual # of subjects enrolled
Sub-specialty 5 Sub-specialty 5: In the past year, how many studies were conducted in this sub-specialty? # of Investigator Initiated Observational Studies in this sub-specialty # of Investigator Initiated Therapeutic Studies (Phase I - III) in this sub-specialty # of Investigator Initiated Device Studies in this sub-specialty # of Industry Sponsored Trials in this sub-specialty # of Industry Sponsored Device Trials in this sub-specialty Target # of subject to be enrolled Actual # of subjects enrolled Previous Next
50% Complete Section 5: Research Team Information Please check below all the members of your research team: Medical Director / Principal Investigator Site Administrator / Director Business Development / Feasibility Coordinator Budget / Contract Coordinator Study Nurse Study Coordinator Regulatory or IRB Coordinator Data Coordinator / Data Manager Laboratory Coordinator or Technician Training / Compliance Coordinator Research Pharmacist Is your research team part of a centralized clinical research infrastructure? FTEs How many FTE s (full-time equivalents) comprise the centralized research infrastructure? Medical Director / Principal Investigator Site Administrator / Director Business Development / Feasibility Coordinator Budget / Contract Coordinator Study Nurse
Study Coordinator Regulatory or IRB Coordinator Data Coordinator / Data Manager Laboratory Coordinator or Technician Training / Compliance Coordinator Research Pharmacist How many clinical trials on average are you managing per year? Of those clinical trials, how many are industry sponsored? Are any members of the site research team certi ed through ACRP or SoCRA? Does your Institution encourage research certi cation?, it is encouraged and they cover ALL the associated costs, it is encouraged and they pay for a PORTION of the cost, it is encouraged but they do not pay for any of the associated costs, it is not encouraged How is specimen collection and processing handled at your site? (Please check all that apply) Study nurse collects specimens, processes them and ships them Study nurse collects specimens, study coordinator / study team processes them and ships them Subjects are sent to lab where samples are drawn, then study team processes and ships specimens Subjects are sent to lab where samples are drawn, processed and shipped Please describe how your team approaches developing a recruitment plan for clinical trials? (Please check all that apply) Discussions with PI and research sta Discussions with Inpatient or Outpatient Clinical Sta Clinical Trials O ce Please describe how your team approaches maximizing retention for clinical trials? (Please check all that apply) Coordinator to subject phone calls throughout the study Subject stipends Mailings Automated emails Clinical Trial Management System Previous Next
60% Complete Section 6: Research Team Training Please describe the clinical research training the research team has completed. (Please check all that apply) Human Subjects Protection Human Subjects Protection - CITI Institution developed clinical research training Good Clinical Practice Investigational Drugs / Devices Good Clinical Practice Investigational Drugs / Devices - CITI Good Clinical Practice Investigational Drugs / Devices, : Is the training required or suggested? Required Suggested Does the required training apply to all members of the study team or select members? All Only select Please indicate select groups: Does your Institution support or fund continuing education opportunities for sta to educational conferences that relate to clinical research?, but does not fund, Institution does fund Previous Next
70% Complete Section 7: Research Compliance Information Does your Institution / site have Clinical Research Standard Operating Procedures (SOPs) in place? Has the Institution, site or principal investigator at the Institution been audited by a regulatory agency (FDA, OIG, OHRP) in the past 2 years? Which agency conducted the audit? FDA OIG OHRP What was the reason for the FDA audit? For cause Routine Re-audit Investigator IRB What was the outcome of the FDA audit? Action Indicated Voluntary Action Indicated O cial Action Indicated Does your site have a COI Management System? Previous Next
80% Complete Section 8: Research Facility Information Do you have the following facilities / equipment / resources available on site? Dedicated research space to conduct study visits Adequate space to conduct study visits Overnight research space < 24 hours Overnight research space > 24 hours Satellite sites used for subject recruitment Satellite sites used for clinical trial conduct Blood Pressure Monitors Scale Wheel chair accessible scale Stadiometer Height and Head circumference (length) measure 12 lead ECG machine Local laboratory for analysis of safety labs Adequate space to process and ship specimens Adequate space to store specimens Centrifuge Refrigerated Centrifuge Specimen Refrigerator Specimen Freezer (-20 C) Specimen Freezer (-80 C) Research Pharmacy Psychological Assessments (IQ, Behavior, Achievement, Developmental, etc.) Ability to record / videotape study visit assessments Experience with electronic data capture Experience with electronic diaries, surveys, etc. Experience with pediatric PK/PD studies High speed internet access International fax / telephone line Monitoring Space Secure, climate-controlled, long term record archival facility On-site record archival O -site record archival Electronic Health Records Tracking system for laptop use for research Tracking system for tablet use for research Tracking system for smartphone use Please provide any comments from the chart in Section 8 here:
90% Complete Section 9: Investigational Drug / Product Information Does your site employ a research pharmacist?, we have research dedicated sta, we have research dedicated sta as part of the hospital pharmacy services, we use hospital provided pharmacy services If your site has a research pharmacist(s), how many full-time equivalents (FTE s) do you have? Is all investigational product stored separately from non-investigational medications? Most (please explain) Does the Institution/site require Good Clinical Practice (GCP) training for personnel managing investigational products? Does the Institution/site have Standard Operating Procedures (SOPs) for investigational drug receipt, management, temperature monitoring and closeout? Does the Institution/site have Standard Operating Procedures (SOPs) for drug disposal? Any other information that you would like to share regarding your site that is unique to conducting pediatric clinical trials? Previous Submit