DOCUMENTS
WHO AM I?
IT'S ALL PROTOCOL
Medical Abbreviations
MISC.
100
A document that describes the objective(s), design, methodology, statistical considerations and organization of the trial.
What is a Protocol
100
I work under the delegation of the PI to help select eligible patients, collect data, input data and overall manage the clinical trial from beginning to end
Who is the CRC or research coordinator
100
The number of subjects in a class or group intended to be enrolled into a trial
What is Enrollment Target
100
NKDA
What is no known drug allergies
100
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.
What is GCP
200
A tool used to collect or enter data either by paper or on a computer. All data on each patient participating in a clinical trial are documented on this
What is a Case Repport Form/CRF
200
I come to your site during the study or following the closure to ensure that thte dat collected is sound. I work for a sponsor, CRO or the FDA
Who is the Auditor
200
The criteria that must be met in order to participate in a study
What is Inclusion criteria
200
K
What is potassium
200
The amount of drug administered to a patient or test subject at one time or the total quantity administered
What is Dose
300
All information in the original records, and certified copies of original records of clinical findings, medical record, a post-it or and electronic version
What is a Source Document
300
I am the primary point of contact for the sponsor and the CRO
Who is the Project leader
300
A variable that pertains to the efficacy or safety evaluations of the trial
What is an End Point
300
Biopsy
What is BX
300
An untoward medical occurrenc in a patient or clinical investigation subject administerd a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
What is an AE
400
Provides an overview of the person's experience and overall qualifications
What is a CV or curriculum vitae
400
I am ther person responsible for the conduct of the trial
What is a PI or principal investigator
400
Give me a single, double or triple...I'm not biased!
What is a blind study
400
Interpret this sentence: The pt. should be NPO for the FBS test and should DC his BP med. after his SOB complaints.
What is "The patient should have nothing by mouth for the fastig blood sugar test and should discontinue his blood pressure medication after his complaint of Shortness of Breath.
400
The porcess of assigning trial subjects to treatment or control groups using an element of change to determine the assignments in order to reduce bias.
What is Randomization
500
This lists all of the clinical and pre-clinical data on the investigational product
What is a Investigator's Brochure or IB
500
Researchers, ideally independent of the trial data . They periodically review data from blinded, placebo control trials. This group can stop a trial if it finds toxicities or if treatment is proved beneficial
Who is the DSMB or who is the Data and Safety Monitoring Board
500
The reason for performing the trial in terms of the scientific questions to be answered
What is the Objective
500
Interpret this sentence:The patients PMH indicates NIDDM, which is c/w my A. I would like to change the RX from BID to QID. He c/o blurry vision OU, so would like to refer to a specialist for TX. Lastly, I want a BX of the BCC on his nose...it's ghastly!
The patients past medical history indicates Non Insulin Dependent Diabetes Mellitus, which is consistent with my Assessment. I would like to change the treatment from twice a day to four times a day. He complains of blurry vision both eyes, so would like to refer to a specialist for treatment. Lastly, I want a biopsy of the basal cell carcinoma on his nose...it's ghastly!
500
Interpret this sentence: The IRB called concerned that our ICF language was not consistent with GCP. Also the SAE submitted for the patient is not listed in the CRF, according to our CRA. Did you complete the updates to the PI's CV updates? I've worked on our SOP, but feel like I'm having an ADR and want to go lie down.
The Institutional Review Board called concerned that our Informed consent form language was not consistent with Good clinical practice. Also the Serious Adverse event submitted for the patient is not listed in the case report form, according to our clinical research associate. Did you complete the Prinicipal Investigator's Curriculum Vitae updates? I've worked on our standard operating procedures, but feel like I'm having an adverse drug reaction and want to go lie down.
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