CRA Flashcards
I’m part of the BACR here in Bulgaria. After graduation I knew I wanted to do something in the research field but I didn’t want to be the person actually carrying out the research and that was kind of how I stumbled upon the role of a CRA after that I started looking at CRO and organizations in the area and that’s where I found BACR. What I really liked about BACR was that they had a program in place designed to train us to take on the role of the CRA so he weren’t just being thrown out in the field and he expected to figure out what we were supposed to be doing we just finished our first week in the program and while it’s been hectic I’ve definitely learned more in this week than I can say I learned in some classes in college and it has me really excited to keep moving forward in the program to see what’s in store.
Аз съм част от BACR тук в България. След дипломирането си знаех, че искам да направя нещо в изследователската област, но не исках да бъда човекът, който действително извършва изследването и по този начин се натъкнах на ролята на CRA, след което започнах да разглеждам CRO и организации в района и там открих BACR. Това, което наистина ми хареса в BACR, беше, че имаха програма, предназначена да ни обучи да поемем ролята на CRA, така че той да не бъде просто изхвърлен на полето и той очакваше да разбере какви трябва да бъдем правейки, току-що завършихме първата си седмица в програмата и макар че беше напрегнато, определено научих повече през тази седмица, отколкото мога да кажа, че научих в някои класове в колежа и наистина ме вълнува да продължа напред в програмата, за да видя какво има в магазина.
I picked BACR because I found it kind of hard to break into the biotech pharmaceutical industry after Medical of University graduation with the Pharmacy degree and there was a great opportunity to get in with a really up-and-coming great reputation. It just seemed like a really great opportunity.
Избрах BACR, защото ми беше трудно да пробия в биотехнологичната фармацевтична индустрия след завършване на Медицински университет със степен по фармация и имаше страхотна възможност да вляза с наистина възходяща репутация. Просто изглеждаше като наистина страхотна възможност.
queries
query
запитвания
запитване, оспорвам, питам
a question, especially one addressed to an official or organization.
a spokeswoman said queries could not be answered until Monday
clinical trial supplies
консумативи за клинични изпитвания
within project timelines
в рамките на сроковете на проекта
compliance
съответствие, съгласие
the action or fact of complying with a wish or command.
they must secure each other’s cooperation or compliance
The document that describes the objectives, design, methodology, statistical considerations, and organization of a trial is called:
Protocol
Contract Research Organization is defined as:
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.
When a sponsor transfers any or all of the sponsor’s trial-related duties and functions to a CRO, the ultimate responsibility for the quality and integrity of the trial data shall reside with:
the sponsor
The informed consent form of the trial subject to participate in a particular trial must be:
All of the above - in writing, signed, dated.
The investigator conducting a trial should be qualified by
Education, training and experience
The investigator:
should not allow monitoring and auditing by the sponsor
The subject’s participation in the trial is voluntary and the subject may refuse to participate or can withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
True
The subject should receive a copy of the signed and dated written informed consent form and any other written information provided to the subjects:
Prior to participation in the trial
Which is not а monitor’s responsibility:
Obtaining informed consent from the trial subject.
