North Adelaide SA / CHCA / CALVARY HEALTH CARE ADELAIDE EXPEDITED REVIEW / State/Territory / Expedited Review / /
Country
Australia / /
Currency
USD / / /
Event
FDA Phase / Person Communication and Meetings / /
Facility
University of Adelaide University / CHCA hospital / Hospital Calvary Wakefield Hospital Calvary Central Districts Hospital Calvary Rehabilitation Hospital / Connery House c/o Calvary North Adelaide Hospital / Calvary North Adelaide Hospital Calvary Wakefield Hospital Calvary Central Districts Hospital Calvary Rehabilitation Hospital / /
IndustryTerm
web-based tool / satisfactory insurance cover / study protocol / web-based data collection / drug/device / research / investigational product / personal medical insurance cover / adequate insurance cover / /
MedicalCondition
disease / cognitive impairment / /
MedicalTreatment
placebos / contraception / drug therapy / /
Organization
National Health and Medical Research Council / PI / Calvary North Adelaide Hospital Calvary Wakefield Hospital Calvary Central Districts Hospital Calvary Rehabilitation Hospital / Therapeutic Goods Administration / HUMAN RESEARCH ETHICS COMMITTEE / Aboriginal Health Council of South Australia AHREC / Contract Research Organisation / University of Adelaide University / CALVARY Institution / CHCA HREC / Research Office / c/o Calvary North Adelaide Hospital / Dr Sepehr Shakib MBSS Director Department of Clinical Pharmacology Royal Adelaide Hospital Associate Professor Judy Magarey DipNurs / School of Nursing / CHCA Human Research & Ethics Committee / /
investigator / NON-SPONSORED TRIALS INVESTIGATOR / Institutional Indemnity Unapproved Drugs Investigator / additional information INVESTIGATOR / Islanders The chief / PRINCIPAL INVESTIGATOR / Chief Executive Officer / A - FULL HREC REVIEW The chief investigator / Site CEO / Principal Investigator and Co-Investigator / CEO / Governor / Member Visiting Medical Officer / Honours PhD Masters Registrar Quality Assurance Data Audit In-House Questionnaire CEO approval letter Final Study Protocol Participant Information Sheet / research worker / Chair / / chief / /
Product
Unapproved drug / Register2 / Marketed drug / /
ProvinceOrState
South Australia / /
Region
South Australia / /
Technology
Radiation / PARTICIPANT CONSENT FORM PROTOCOL / Honours PhD Masters Registrar Quality Assurance Data Audit In-House Questionnaire CEO approval letter Final Study Protocol / stem cells / Investigator-Initiated study protocol / Initiated study protocol / /
INSTRUCTIONS TO APPLICANTS FOR CALVARY HEALTH CARE ADELAIDE (CHCA) HUMAN RESEARCH ETHICS COMMITTEE (HREC) APPROVAL Applicants should review the NHMRC National Statement on Ethical Conduct in Human Research[removed]at ht