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Current Controlled Trials allows users to search, register and share information about randomised controlled trials. Access to all the information on this site is free; charges for the registration services offered by Current Controlled Trials are available on request. Publication services are also available via the range of open access peer-reviewed journals published by our sister company, BioMed Central.

ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.

MedDRA — the Medical Dictionary for Regulatory Activities — is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.
The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) as a measuring unit have become the gold standard for international drug utilization research.

The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base.

This index of regulatory and procedural guidance provides links to pages listing documents relevant to the operation of the centralised procedure specifically pre- and post-authorisation issues. Each page provides an overview of the key legislative texts, guidelines, procedural advice, templates, SOPs etc. which are available to applicants to guide them through the relevant procedural steps. This index excludes human scientific guidelines as well as general information related to the Agency’s scientific committees. Each page accessible from this page is located in its relevant topic area.
 

EudraCT is a database of all clinical trials commencing in the Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC.This site is the sponsor and Paediatric Investigation Plan addressee (PIP addressee) interface which gives these groups access to the EudraCT application.

 

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

The Department of Health and Human Services (HHS) is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS represents almost a quarter of all federal outlays, and it administers more grant dollars than all other federal agencies combined. HHS’ Medicare program is the nation’s largest health insurer, handling more than 1 billion claims per year. Medicare and Medicaid together provide health care insurance for one in four Americans. HHS works closely with state and local governments, and many HHS-funded services are provided at the local level by state or county agencies, or through private sector grantees. The Department’s programs are administered by 11 operating divisions, including eight agencies in the U. S. Public Health Service and three human services agencies. The department includes more than 300 programs, covering a wide spectrum of activities. In addition to the services they deliver, the HHS programs provide for equitable treatment of beneficiaries nationwide, and they enable the collection of national health and other data.
fda

The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.

Міністерство Охорони Здоров'я України. Державний Експертний Центр.
Центральна комісія з питань етики Міністерства охорони здоров’я України — незалежний науково-експертний орган, який забезпечує дотримання прав, безпеки та благополуччя пацієнтів (здорових добровольців), досліджуваних всіма учасниками клінічних досліджень шляхом схвалення клінічних досліджень, що ґрунтується на експертній оцінці етичних та морально-правових принципів клінічних досліджень.

The Association of Clinical Research Organizations (ACRO) represents the world's leading clinical research organizations (CROs). Our members provide specialized services that are integral to the development of drugs, biologics and medical devices. ACRO advances clinical outsourcing to improve the quality, efficiency and safety of biomedical research. Each year, ACRO’s members conduct thousands of clinical trials and provide related drug development services in more than 115 countries while ensuring the safety of nearly 2 million research participants.
Non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia.
Association of clinical research professionals.

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These Standard Operating Procedures (SOP) delineate the structure, functions and process (including the review criteria) to be followed by the Ethics Review Committee of the WHO Regional Office for the Western Pacific (the Committee or WPROERC) for ethical review of research proposals submitted to it. The SOP will override any other administrative rules or procedures specified elsewhere before October 2010. The relevant section of the WHO Western Pacific Regional policy handbook dealing with this issue will be revised accordingly.
 

STANDARD OPERATING
PROCEDURES FOR CLINICAL
INVESTIGATORS
Informed Consent Form Templates

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