External Resources


Indiana Access to Public Records Act

Access to Public Records Act permits Indiana citizens access to documents by meeting certain parameters and requirements.

IC 5-14-3

 

 

Indiana Medical Malpractice Act

Indiana Medical Malpractice Act covers the financial responsibility of health care providers.

IC-34-18-4

 

Indiana Tort Claims Act

Indiana Tort Claims Act covers tort claims against government entities and employees.

IC 34-13-3

 

Expanded Access to Investigational Drugs for Treatment Use

FDA requirements for the use of investigational new drugs and approved drugs where availability is limited by a risk evaluation and mitigation strategy when the primary purpose is to diagnose, monitor, or treat a patient’s disease or condition. The goal is to facilitate the availability of such drugs to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient’s disease or condition.

21 C.F.R. §§ 312.300 -312.320

 

Financial Disclosure By Clinical Investigators

FDA regulations that require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsors and the investigators regarding a product in a study or a sponsor of a study.

21 C.F.R. § 54

 

Informing Investigators

Sponsor’s responsibility to keep investigators informed of new observations discovered by or reported to the sponsor on a drug, particularly with respect to adverse effects and safe use.

C.F.R. 312.55

 

Unanticipated Events for Drugs

Sponsor’s responsibility to select qualified investigators  providing them with the information they need to conduct an investigation properly

21 C.F.R. 312.50

 

Humanitarian Use Device

FDA procedures and requirements governing the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the United States per year.

21 C.F.R. Part 814 Subpart H

 

Investigational Device Exemptions

FDA procedures and requirements governing the use of investigational devices, including procedures and requirements for the submission to, and review by, the FDA.

21 C.F.R. 812

 

Investigational New Drug Application

FDA procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by the FDA.

21 C.F.R. Part 312

 

U.S. Food and Drug Administration (FDA)

The United States Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing applications and reclassification petitions for medical devices. Please see the links below for the most commonly accessed FDA information.

Additional FDA links for clinical trial related information and documents have been provided.  You will find these FDA links helpful as you prepare, manage, and close your trial.

Association for the Accreditation of Human Research Protection Programs, Inc.

Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), an independent, non-profit accrediting body, that promotes high-quality research through an accreditation process to help organizations strengthen their human research protection programs by meeting rigorous human research standards for quality and protection.

 

Health Insurance Portability and Accountability Act

Health Insurance Portability and Accountability Act (HIPAA): Provides the ability to transfer and continue health insurance coverage, reduces health care fraud and abuse, mandates industry-wide standards for health care information and processes, and requires the protection and confidential handling of protected health information.

Health Insurance Portability and Accountability Act of 1996, as codified at 42 U.S.C. § 1320d

 

CMS Medicare Secondary Payer

CMS Medicare Secondary Payer (MSP) is the general term used when the Medicare program does not have primary payment responsibility; rather another entity has responsibility for paying before Medicare.

 

Centers for Medicare & Medicaid Services

Centers for Medicare & Medicaid Services (CMS) is a federal agency within the United States Department of Health and Human Services that administers the Medicare program and partners with state governments to administer Medicaid, the State Children’s Health Insurance Program, and health insurance portability standards.

 

ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants.

 

Belmont Report

Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

 

Declaration of Helsinki World Medical Association Recommendations

Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association.

 

ICH Harmonized Tripartite Guideline for Good Clinical Practice

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.

 

IU Health Methodist Research Institute (MRI)

IU Health Methodist Research Institute (MRI) is the central trial coordination center for multiple IU Health Hospital facilities.  It supports the management of both administrative and clinical aspects of pharmaceutical and device research trials (e.g., clinical trial coordination, regulatory activities, enrollment of subjects, collection of data, and study close out activities).

 

IU Health Investigational Drug Services

Investigational Drug Services (IDS), part of the IUHealth Pharmacy Department, specializes in investigational drug studies and coordinates studies for both inpatient and outpatient protocols at IUHealth University Hospital, Riley Hospital for Children at IUHealth, and IUHealthMethodist Hospital, and IUHealth Simon Cancer Center.

 

IU Health

IU Health is a healthcare system that partners with IUSM by providing patients access to innovative treatments and therapies.