כלי מחקר: ניסויים קליניים

BGU Human Subjects Research Committee.
When proposing research with human subjects, researchers are required to provide accurate information about their research and to obtain institutional approval before conducting the research.

In this website you can find information about the Committee's function and what is needed in order to submit a research approval request. The entire approval request process is carried out via this website.

Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The Belmont Report (1979) identifies three basic ethical principles that underlie all human subject research. These principles are Respect for persons, Beneficence, and Justice.

ספר מקטלוג הספריה
W20.55.H9 H673 2007

International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects to ensure that the RIGHTS, SAFETY and WELLBEING of the trial subjects are protected. Ensure the CREDIBILITY of clinical trial data.

International Conference on Harmonization (ICH) documents

A draft code of ethics on human experimentation drawn up by the World Medical Association was published in the
British Medical 7ournal of 27 October 1962. The original draft of this was in English. A revised version was
accepted as the final draft at the meeting of the World Medical Association in Helsinki in 7une 1964. The
original of this draft was in French, of which the W.M.A.'s English version is printed below. It is to be known as the
Declaration of Helsinki.

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data....

The global source for clinical trials information: offering news, analysis, study grants, career opportunities, and trial listings to professionals and patients.

eCliniqua provides authoritative news, views, insights and opinion on challenges related to clinical research, clinical trial design, data management and technology solutions. Written by a superb tandem of expert clinical reporters, eCliniqua highlights innovations in development planning and protocol design; new approaches to sponsor-CRO and sponsor-site relationships; novel patient recruitment and retention strategies and practices; project management; emerging and established electronic clinical trial technologies and standards; regulatory trends and compliance; pharmacovigilance; and much more.
Cambridge Healthtech Institute

The mission of the Food and Drug Administration (FDA) is the protection and advancement of public health by helping speed innovation on FDA regulated products. ;
Underlying FDA regulatory decisions are the application of advanced technology and science based standards.;
The objective of FDA research is to anticipate and resolve scientific and technical challenges before they become unsupported impediments, thus enabling the regulatory mission of FDA....FDA research is the common pathway to enhance the success of NIH, United States Department of Agriculture (USDA), National Science Foundation (NSF), and other’s technology advances in public health by helping make their research directly relevant to determinations of safety and efficacy of new public health products.

International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.
Frequently Asked Questions about Clinical Trials Registration:

NCRR provides clinical and translational researchers with the training and tools they need to transform basic discoveries into improved human health.

Clinical trials are registered with ClinicalTrials.gov via a web based data entry system called the Protocol Registration System (PRS).

The CONSORT Statement is intended to improve the reporting of a randomized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results. It emphasizes that this can only be achieved through complete transparency from authors.

Upcoming in 2016

מאגר המאפשר חיפוש מידע עבור ניסויים קליניים מבוקרים.

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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 the sister company, BioMed Central.

Registered clinic trials in the European Union.

Registered randomised controlled trials and other studies designed to assess the efficacy of health-care interventions worldwide.

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Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available

Open Knowledge is developing OpenTrials, an open, online database of information about the world’s clinical research trials. We are funded by The Laura and John Arnold Foundation through the Center for Open Science. The project, which is designed to increase transparency and improve access to research, will be directed by Dr. Ben Goldacre, an internationally known leader on clinical transparency.

OpenTrials is building a collaborative and open linked database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial:

registry entries
links, abstracts, or texts of academic journal papers
portions of regulatory documents describing individual trials
structured data on methods and results extracted by systematic reviewers or other
researchers
Clinical Study Reports
additional documents such as blank consent forms, blank case report forms, and protocols
The intention is to create an open, freely re-usable index of all such information, to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive standards around open data in evidence-based medicine.

The Clinical Trials Search Portal provides access to a central database containing the trial registration data sets provided by the registries listed on the webpage. It also provides links to the full original records.
Includes ClinicalTrials.gov.