GCP Flashcards
What are observational studies?
draws conclusions about the possible effect of a treatment on participants into a treatment group vs a control group
What are interventional studies
Where the participants receive some kind of intervention like a new medicine in order to evaluate it.
Give examples of interventional study types?
- clinical trials of investigational medicinal products
- advanced therapy medicinal products
- mechanistic studies
- clinical investigations
Name examples of observational studies
- cross sectional studies
- case control studies
- cohort studies
Setting where research can happen
Hospitals
Primary care
Community care
Residential care
Research stages
Stage 1- idea, design and planning
Stage 2- applications and approvals
Stage 3- study set up
Stage 4- study conduct; recruitment and data collection
Stage 5- analysis and results
Protocol
Describes the background, rationale, objectives, design, methodology, and statistical considerations.
Principles of good practice
There are 10 principles which include things around rights, safety, having certain qualifications, and ethical principles.
Clinical trial
Any investigation in human subjects, other than a non-interventional trial intended
A. To discover or verify clinical effects of a medicinal product.
B. Identify adverse red actions to a product
C. To study absorption, distribution, metabolism and excretion of one or more products with the object of safety and safety.
UK Policy Framework for Health and Social Care Research (2017)
Sets out the principles which underpin high quality research in the UK and responsibilities of key organisations and individuals.
Econsent
An approach sponsors and researchers are increasingly keen to adopt. It enables potential research participants to be provided with the information they need to make a decision via a computer, tablet, smartphone or multimedia. Enables informed consent to be documented using electronic signatures.
Econsent various forms
Online forms
Digital signature
Clickwrap agreements
Biometric consent
Email or SMS confirmation
Stages of the study set up
Site identification
Assess capacity and capability
Practical arrangements
Contracts
Site initiation
Research approvals
What are substantial amendments?
The definition of a substantial amendment varies slightly between MHRA regulated trials and other types of study.
How are amendments implemented?
New versions of documents, including protocol amendments, will be released once they have been approved. Usually, one member of the study team circulated updated documents to their colleagues.
Source data
Where a piece of information or a data point is first captured, it is therefore the original record and is vital for audit trail purposes and overall trial management.
describe stage one of the research process
all research starts with an idea or a problem which is formulated into research q. once identified, methodology is developed to ensure that the study is statistically sound. written instructions are developed to specify what data is needed and how it is collected an from whom
describe stage three of the research process
practical steps are taken to ensure fully prepared to conduct study to highest levels before recruiting of participants happens.
describe stage 4 of research process
once approved, study can be conducted so participants recruited, data collection and processed. informed consent and recruitment into studies occurs, recording o study data
describe stage 5 of research process
data is analysed to established to answer the research q. recommendations can be made which can then bring about improvements in treatment.
what is good clinical practice
international ethical and scientific quality standard for designing, conducting, recording and reporting trails involving participation of human subjects
what is a non CTIMP
any study that is not identifiable as CTIMP and so doesn’t fall within the scope of clinical trials.
informed consent definition
process in which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of trial that are relevant to subject decisions to participate. informed consent is documented by means of written signed and dated informed consent form
what are some of the main points of the informed consent
- it is a process, not a single event
- voluntary
- informed
- documented
why is informed consent important
- rights, safety and wellbeing of participants comes before all else
- without informed consent the data collected can be invalid or need to destroyed
- indemnity could be invalidated without informed consent insurance
- failing to seek informed consent impacts on reputation of our organisations
what are the 3 key roles in research process
- sponsor
- chief investigator
- principal investigator
what is the role of the sponsor
responsible for initiation, management and financing of the study. must ensure all insurances, indemnities etc are in place.
what is role of the chief investigatior
takes primary responsibility for the conduct of the study and will delegate some of their duties but always remain responsible for them
what is the role of the principal investigator
takes responsibility for initiation and conduct of the study at the site
how is randomisation done in our studies
participants being randomised. randomised trials can be ‘blinded’ to ensure participants don’t know which treatment they’re receiving. participants only unblinded for safety reasons or medical need
