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Documents
Who am I
It's all Protocol
Informed Consent
Misc.
100
A Log outlining the roles and responsibilities of the staff members which are chosen by the PI
What is a delegation log
100
I work under the delegation of the PI to help select eligible study subjects, collect data, input the data and overall manage the clinical trial from start to finish
What is a clinical research coordinator
100
The number of subjects in a class or group intended to be enrolled into a trial
What is Enrollment Target
100
When you seek informed consent from someone, you are showing respect for their
What is Autonomy
100
A voice or web system which helps register new patients into a study, randomize enrolled subjects, verify drug shipment and discontinue a subject from a study
What is IVRS/IWRS
200
A tool used to collect or enter data either by paper or on a computer screen; All data on each patient participating in a clinical trial are held and/or documented on this...
What is a Case Report Form
200
I come to your site during the study or following the closure of the study to ensure that the data collected is sound. I can work for a Sponsor, a CRO or the FDA for example
What is an Auditor
200
The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study
What is Inclusion Criteria
200
These provide a uniform standard for designing, conducting, recording, and reporting during a clnical trial
What is ICH guidelines
200
the specific primary reason for which the investigational product is being administered
What is Indication
300
All information in original records and certified copies of original records of clinical findings...this can be a medical record, a post-it, or an electronic medical record
What is a source document
300
I am the primary point of contact for the sponsor and the CRO
What is a project leader
300
A variable that pertains to the efficacy or safety evaluations of the trial.
What is an End Point
300
PI: It would be in your best interest to enroll in the clinical trial Patient: I'm just not sure I want to commit to a study PI: Well, the way I see it, it's your best option for your condition Patient: Ok, I guess I will sign up. This is an example of:
What is Coercion
300
An independent committee consisting of medical, scientific, and non-scientific members whose responsibility is to ensure the rights, safety, and well being of human subjects involved in a trial.
What is Institutional Review Board (IRB)
400
Provides an overview of the person's experience and overal qualifications
What is a Curriculum Vitae
400
I evaluate the clinical data and ensure that you are being compliant with the protocol. I perform IMV, SIV and close out visits.
What is CRA or monitor
400
An SAE is any untoward medical occurrence that at any dose: • Results in death, • Is life-threatening, • Results in persistent or significant disability/incapacity • Requires inpatient hospitalization • Is medically significant
What is an SAE
400
I know that my doctor said this study may not directly benefit me...but she is such a nice lady, she wouldn't tell me about the study if she didn't think it was perfect for me... This is an example of:
What is therapeutic misconception
400
Detailed, written instructions to achieve uniformity of the performance of a specific function or procedure.
What is Standard Operating Procedure
500
This lists all of the clinical and nonclinical data on the investigational product which is relevant to the study
What is an Investigator's Brochure
500
You may not like when I query you, but just remember I'm just doing my job
What is Data management
500
Explain this study: A Phase II, Randomized, double-blinded two-year study with topical application...
What is a study that has completed pre-clinical and Phase I requirements in which study subjects will be randomized into groups of treatment, double blinded meaning that PI and subject or study team and subject are masked to the treatment...
500
Patient has been informed of the purpose of the study, the risks and benefits have been covered as well as alternatives to being in a study. The pt. has signed the ICF, has been given a signed copy, has had a chance to ask questions and seek answers and understands that they are volunteering to particpate in the study...
What is the Informed Consent Process
500
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
What is Randomization