Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Introduction to Pharmaceutical Science (CLP112) > Roles and Responsibilities of a CRC/CTA (13) > Flashcards

Roles and Responsibilities of a CRC/CTA (13) Flashcards

You may prefer our related Brainscape-certified flashcards:
Biology 101 flashcards
1
Q

What is a Clinical Trial?

A

Any investigation in human subjects intended to discover or verify the clinical, pharmacological/ and or other pharmacodynamic effects of an investigational product(s), and/ or study absorption, distribution, metabolism and excretion of an investigational product (s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is ADME?

A

Absorption
Distribution
Metabolism
Excretion

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What is human research? What does it involve?

A

Is research involving human participants, who may participate through:
-taking part in survey, interviews or focus groups

  • undergoing psychological, medical testing or treatment (clinical trial)
  • being observed by researchers (observational study-psychiatry trial)
  • researchers having access to their personal documents or other materials (medical records-database review)
  • The collection and use of their body organs, tissues or fluids (e.g skin, blood, urine, saliva, bones, hair, other biopsy specimen) (genetics study)
  • Their information (in individually identifiable, re-identifiable or non-identifiable form) being assessed as part of an existing published or unpublished source or database.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Define Clinical Research Coordinator

A

A specialized research professional working with, and under the direction of, the Clinical Investigator

-Handles the bulk of daily clinical trial activities

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Where do Clinical Research Coordinator’s work?

A

Work in the hospital

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Who leads the study of the Clinical Trial?

A

Clinical Investigator

Legally responsible for the management of a clinical trial at a site
PI (principle investigator)

-Lead the study

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What does a CRC do? IAD

A

Identify- identification of side effects of the IP (investigational product)

Assess- check on the patients well being/ safety

Discuss- discussing the informed consent, drug usage, trial participation, patient counselling

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What are the background of CRCs?

A

Medical professionals
-Nurses, physician assistants

Non-medical professionals

  • science background
  • experience based training
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Training of CRC:

A

On the job training by experienced CRCs
-may be done by sponsored companies (CRA trains CRC)

Investigator meetings
PI and CRC attend, global meeting (how to conduct the study and all about the study)

Informal Interaction
(networking)

Formal training courses

  • Professional organizations
  • Universities
  • NYP poly
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What are the skills and personalities needed to be a CRC?

A

Mixture of duties:

  • Administrative- paper work
  • Business- project management
  • Medical - patient assessment
  • Patient oriented-patient education, counselling, patient well being

Skills:

  • have extremely good organizational skills
  • Be detail-oriented
  • Be people oriented
  • Be self confident, flexible and adaptable to change
  • Be focused, manage time well and follow through on problems and commitments (challenging, fast paced)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What are the roles and responsibilities of a CRC?

A

Play a key role in Clinical Research- they support, guide and motivate research participants while ensuring that the studies are carried out accurately, and with scientific and ethical integrity

Regardless of the particular research settings, the successful functioning of clinical research team revolves around the CRC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Overview of CRC’s responsibilities:

A
  1. Assist in evaluating new protocol for feasibility at the site
  2. Prepares the site for conducting the study
  3. Participates in Informed Consent Process

4.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

CRC responsibilities:

What does assisting in evaluating new protocol for feasibility at the site involve?

A
  • Review the protocol and other materials, such as the Investigator Brochure and informed consent form
  • Review subject eligibility requirements
  • Assess the ability to meet study timelines in light of other site commitments and overall feasibility
  • Assess the resources necessary to do the study, including people, physical space, material
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What does the investigator brochure include?

A

aka product leaflet
Includes anything about the drug
Pre clinical results/ Adverse event
Toxicity

IP= non-marketed drug

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

CRC responsibilities:

What does preparing the site for conducting the study involve?

A

Train the people involved

Set up and organize study files

Create or review study specific source documents and materials

Disseminate (spread/share/update) trial information to the rest of the study team

Create advertising, if appropriate

Prepare documents for submission to ethics committee

Collect the documents needed to initiate the study

Attend investigator meeting, as appropriate

Middle-man between doctor, patient and sponsor

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

CRC responsibilities:

What does participating in informed consent process involve?

A

Assist in writing consents

Present and discuss the informed consent form to potential subjects and answer their questions

Ensure that all necessary signatures and dates are obtained correctly in the informed consent forms

Document, distribute and file signed informed consent forms appropriately

Ensure that all amended consent forms are appropriately implemented and signed

17
Q

CRC responsibilities:

What does managing study conduct throughout the trial involve?

A

Contact and screen potential subjects

Recruit subjects

Schedule subject and sponsor visits

Prepare for each subject visit to ensure that all appropriate study procedures are done

Assist the investigator with study subject visits

Ensure that all necessary data is gathered and recorded in the appropriate documents and case report forms

Review data collection forms entries for completeness, correctness and logical sense.

Review the source documents (medical records) and forms of adverse effects (side effects) that may be missed

18
Q

CRC responsibilities:
What does managing study conduct throughout the trial involve?

part 2

A

Work with sponsor monitors (CRAs) during monitoring visits

Make corrections to case report forms, if appropriate

Resolve data queries

Ensure that study documents are complete, current and filed correctly

Ensure that study drugs accountability is done correctly for each subject and overall

Manage laboratory procedures (drawing blood samples, processing, packaging and shipping)

Record study supplies (lab kit, drug supply, study equipment) as necessary

Manage payment to study subjects, if appropriate

Assist studies closeout activities at the end of the study

19
Q

Other duties the CRC is in charge of:

A

Maintain regular communications with sponsors and/or CROs, regulatory bodies, and the institution

CRO=contract research organisation

Collaborate with other department (laboratory, pharmacy, etc) as necessary

Assist the investigator with financial aspects of the trial, including budgeting and contracts

Solves problems

Coordinate sponsor and/or regulatory audits

Professionally represent the site to all people/ organizations in the best possible light

20
Q

What are the career options for CRC?

A

In house clinical trial division in pharmaceutical companies

Clinical research organizations

Clinical trial units in hospitals

Clinical trial coordinators in specific departments/services

Regulatory authorities

21
Q

What is the role of a Clinical Trials Assistant?

A

Work with the pharmaceutical companies/CROs

Administrative position

Support the clinical team in managing clinical trials project

(no patient interaction)

22
Q

What are the typical roles and responsibilities of a Clinical Trial Assistant?

A

Assist the clinical trial team with accurate updating and maintaining clinical systems that track study site compliance and performance according to project timelines

Assist the clinical trial team in the preparation, handling, distribution, filing and archiving of clinical documents and reports according to SOPs

Assist the clinical trial team leader (CRAs) with preparation and distribution of study related supplies to various study sites

Assist with the tracking and management of CRFs (Case report forms)

Assist with tracking data queries and data management flow

23
Q

What are the opportunities working in the clinical trial field?

A 
High starting pay 
Flexible working schedule 
Better benefits 
-regional exposure as you travel for training and meetings 
-team building seminars
-other skills training

Specialize and expertise

Introduction to Pharmaceutical Science (CLP112) (9 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions