IZKS Mainz | Information for Investigators

August 29, 2013 – 01:55

Below you will find links and templates for the preparation of permit applications to the relevant ethics committees and federal agencies. The websites of the authorities and the direct references to the legal texts can be found in the section Useful links

Study protocol

ON GOOD CLINICAL PRACTICE ( CPMP /ICH/135/95) Current requirements of the study protocol can be found in Chapter 6 of the NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP / ICH/135/95)

Mainz erhältlich. A study protocol template in German or English on request available at IZKS Mainz.

2013 standarts for all clinical trial protocols in the following publications were also published.

Eudra CT number

Eudra CT number is an identification key opportunity for a clinical trial
) in Europe and is on the website of the European Medicines Agency (EMA)
requested.

Module 1 (Clinical Trial Application form)

Module 1 is the common form for the application for approval by the competent authority and an ethics committee. /CT 1 und wird online auf der Webseite der Europäischen Arzneimittelagentur ( EMA ) erstellt. This form corresponds to the Annex 1 of the Detailed Guidance ENTR / CT 1, and created online on the website of the European Medicines Agency (EMA).

system help bietet ausführliche Anleitungen für die Beantragung der EudraCT Nummer und die Erstellung des Moduls 1. The EudraCT PUBLIC help system provides detailed instructions for applying for the EudraCT number and the creation of the module 1
https://eudract.ema.europa.eu/help/Default.htm # CSHID = undefined

Module 2

/CT 2 (7.3) ist das Formular für den Antrag auf die zustimmende Bewertung einer klinischen Studie durch die Ethikkommission. Module 2 of the Detailed Guidance ENTR / CT 2 (7.3) is the form for the application for the affirmative vote of a clinical trial by the Ethics Commission. The German version can be downloaded from the website of the Working Group of Medical Ethics Committees (AK-EK):

Volunteers information

If you are planning a phase I clinical trial in healthy subjects, you can work through the county medical ethics committees (AK-EK) provided a template for the volunteers to download information.

Source: www.kks-mainz.de

Lippincott Williams & Wilkins SOAP for Family Medicine
Book (Lippincott Williams & Wilkins)

Diversity = better treatment for POC patients

2008-04-03 10:38:34 by darkambition1

According to the studies
white doctors listen more to white patients, talk more than listen to black patients
black HIV patients better off with black doctors?
Researchers have known for years that African-Americans in the midst of a heart attack are far less likely than white patients to receive potentially life-saving treatments such as clot-busting drugs, a dramatic illustration of America's persistent healthcare disparities

Another showing approximately the same reduction

2009-11-11 06:36:09 by Yosarrian0022

In Prostate cancer rates - REMEMBER - it might NOT be the soy having this effect but something that comes along with high soy in the diet - high fruit and vegetable consumption for example or Low meat consumption. The effect here ONLY is seen with tofu consumption which is further indications that it is probably a marker rather than the cause.
Nutr Cancer. 2009;61(5):598-606.
Soy food consumption and risk of prostate cancer: a meta-analysis of observational studies.
Hwang YW, Kim SY, Jee SH, Kim YN, Nam CM.

An ideal rarely reached...

2005-01-05 12:55:14 by Moopheus

To the contrary, scientists are people and people are not often objective and neutral.
Scientists, of course, work harder at being objective because of the limits and goals of the scientific disciplines, but this doesn’t mean personal preferences or ideologies never get in the way of their research.
Unfortunately, the scientific community has its share of ambition, suppression of truth, prejudice, plagiarism, manipulation of data, etc. This is illustrated by Tel Aviv Medical School’s Professor of Urology Alexander Kohn in his False Prophets: Fraud and Error in Science and Medicine (1986), by Broad and Wade’s Betrayers of the Truth: Fraud and Deceit in the Halls of Science (1982), and other books and articles

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Foreign companies stop clinical trials in India after government amends rules ..  — Times of India
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