• Research outcomes demonstrate a better way of delivering patient care or services,

healthcare moves forward

(e.g Clots in legs or stockings after stroke study)
• unifies view on best practice since there is evidence
BENEFITS
• Positive questioning and search for optimal practices
• Improved experience and outcomes for participants
• New and improved treatments
• contribute to balanced economy
• innovative and effective services
• increased skill amongst NHS professionals

(idea: As a nurse who aim to provide high quality evedeince based care I learnt to appreciate the
importance of research in helping guide practice, policy leading to better health outcomes.

TYPES OF STUDY
• Observational (cross sectional- case control studies- cohort studies)
• Interventional ( mechanical- clinical trials/investigations of medical devices- clinical trials of
investigational medicinal products)

Stages of a study
1) Idea, design and plan (important: what data is needed, how it should be collected and from whom)
2) Application and approval
3) Study set-up
4) Study, conduct, recruitment and data collection
5) Analysis and results

***all info will be found within protocol. Protocol is a document which describes the background,
rationale, objectives, design, methodology and statistical considerations***

GCP & PRINCIPLES (an international ethical and scientific quality standard for designing,
conducting, recording and reporting trials that involve the participation of human subjects) &
declaration of Hlesinki 1964

If research process is flawed, the info becomes unreliabe , fundamentally undemining day to day
practice of healthcare . Established research principles are reffered to as Good Clinical Practice
(GCP)

Principles
-Rights, safety and well being of trial subjects is above all
-All individuals involved shall be qualified by education, training and experience
-Clinical trials should be scientifically sound and guided nby ethical principles in all aspects
-All clinical information should be recorded, handled and stored in a way that it can be accurately
reported interpreted and verified while confidentialy is being protected at all times
Safe, scientifcally and ethically sound, compliant and has relevant insurance and indemnities,
involves the public, respects privacy and allows people to choose whether they want to participate
or not, correct recording of data, weighing up benefits and risks
*SOS Important to know what standards apply to your study before you begin. This should be clear in
the protocol and supporting documentation

Informed Consent

• Without it, data collected may be invalid or need to be destoyed affecting the overall study and
data integrity
• Without it, insurance/indemnity could be invalidated and participants could take legal action
• Impacts the reputation of the service
PRINCIPLES
• It is a process, not a single event and should be seen as an information cycle
• We receive consent, we do not take it
• It is on going, not a throughout thing and it take time
• All involved in the study have a responsibility within the process
IMPORTANT ASPECTS
• it is a two way discussion with the potential participant (communication skills are vital)
• the sibject consents voluntarily after being informed
• it has to be documented appropriately

THE PROTOCOL
It contains much of the info required to conduct the study at your site but is likely to be supported by
other documentation and trial specific guidance such us: instruction for the study procedures,
patient information sheets which provide ethicaly approved explanation of the study , bank
consent forms and blank case report forms, study specific data collection tools

---it defines (alongside supporting information) and specifies what activities need to happen in order to
conduct the study to ensure consistency in the data collected

SOS*** Keep in mind changes in study for various reasons and changes in the documentation and
proccesses

GOOD DOCUMENTATION
• Attributable: clear who created the source record and when
• Legible: Should be easy to read
• Contemporaneous: should be documented at the time is generated and observed
• Original: the first capture of information is important and avoiding replication is good
• Accurate: Coorect, true, valid and a real represantation of the facts
• Complete: No ommisions or censoring of data recorded

SOS** To maintain participant sasfety at all times and document all adverse effects during the study