Clinical Research History

History

100

The first clinical trial documented was in the Old Testament dates back to 605 BC. What was the trial?

Daniel requested that he and three other children be allowed to eat only bread and water. Daniel and the three children were noticeably healthier and more vivacious than those who were relegated to the wine and meat diet.

200

In 1863 what was first introduced to clinical trials

Placebo

300

What 3 global markets were involved in the ICH?

The EU, Japan and U.S.

400

When did the voluntary consent of the human subject become absolutely essential? (not looking for a year) 

In the Nuremberg Code that was developed in 1947 which outlines 10 basic statements for the protection of human participants in clinical trials.

500

What are the three fundamental ethical principles the Belmont Report mandates?

1- Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. 2-Beneficence: The philosophy of "Do no harm" while maximizing benefits for the research project and minimizing risks to the research subjects; 3-Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally

Nuremberg Code

100

The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of ?

Subsequent Nuremberg Trials at the end of the Second World War

200

How many trials were involved in the Nuremberg Trials ?

12 trials

300

What are the 3 main conclusions of Nuremberg Code?

1- informed consent and absence of coercion; 2-properly formulated scientific experimentation; 3- beneficence towards experiment participants

400

Nuremberg Code mandated human experimentation to be based on the results of animal experimentation ( True or False)?

True

500

The degree of risk to be taken can exceed that determined by the humanitarian importance in order to solve the research question for the overall benefits to society. (True/ False)

False

Declaration of Helsinki

100

Who was the Declaration of Helsinki developed by? ( not a person but an organization)

World Medical Association (WMA)

200

Physicians who combine medical research with medical care should not involve their patients in research (True/False)

False. They should only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

300

Where does the Declaration of Helsinki stand on research with vulnerable subjects?

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

400

What should be done for a potential research subject who is incapable of giving informed consent?

the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them and the research entails only minimal risk and minimal burden

500

The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

1-Where no proven intervention exists, the use of placebo, or no intervention, is acceptable 2-Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention 3-Extreme care must be taken to avoid abuse of this option

ICH

100

What was the purpose of ICH?

To reduce the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration

200

ICH developed a rich and highly specific standardised medical terminology System, what was it called?

MedDRA

300

WHO has it’s own global safety database called WHO-ART and information on it can not be converted into MEDRA form yet ? ( True/False)

False, MedDRA is fully implemented in the WHO global safety database allowing entry and retrieval of information in either MedDRA or WHO-ART.  A mapping bridge is kept updated by WHO and ICH, to allow conversion of WHO-ART coded data into MedDRA, allowing users to readily convert their data and use MedDRA.

400

In ICH there was an agreement to assemble all the Quality, Safety and Efficacy information in a common format for submission, what is it called?

CTD - Common Technical Document

500

The ICH topics are divided into four categories, what are they?

1- Quality Guidelines 2- Safety Guidelines 3- Efficacy Guidelines 4- Multidisciplinary Guidelines

ICH GCP (E6)

100

What does ICH stand for? 

International Conference on Harmonization

200

REB should always be notified with any deviation from Protocol, prior to deviation? (true/false)

False, You should not implement any deviation from, or changes of the protocol without agreement from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects. person designated by the investigator, should document and explain any deviation from the approved protocol. As soon as possible, the implemented deviation to REB.

300

ICH GCP mandates obtaining reason for subject withdrawal? (true/False)

False, Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator or delegate should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.

400

What do you do if a subject is unable to read or if a legally acceptable representative is unable to read ?

impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject’s legally acceptable representative, and after the subject or the subject’s legally acceptable representative has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained

500

According to ICH GCP, what are 6 things that need to be maintained on an electronic data processing system

1- Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data 2- Maintain a list of the individuals who are authorized to make data changes 3-Maintain adequate backup of the data 4- Maintain SOPs for using these system 5-Maintain a security system that prevents unauthorized access to the data 6- Safeguard the blinding, if any