Full study title:

Project Management Members

Name, job title, address, contact details

1.Chief Investigator:

2.Co-investigators:

3.Statistician:

4.Project Manager

5.Key Contact

Funder: Name & details of the contact

Sponsor: Name & details of the contact

Table of Contents

1INTRODUCTION

1.1BACKGROUND

1.2RATIONALE

2 STUDY OBJECTIVES

2.1PRIMARY OBJECTIVES

2.2SECONDARY OBJECTIVES

2.3OUTCOME MEASURES

3 STUDY DESIGN

3.1STUDY METHODOLOGY

3.2SPECIFIC METHODS

3.3SETTING AND TIMESCALE

4PARTICIPANTS AND RECRUITMENT

4.1GROUP

4.2INCLUSION CRITERIA

4.3EXCLUSION CRITERIA

4.4WITHDRAWAL CRITERIA

4.5RECRUITMENT

4.6SAMPLE SIZE

4.6.1SAMPLE FRAME

4.6.2SAMPLING METHOD

5STATISTICS AND DATA ANALYSIS

6ETHICAL CONSIDERATIONS AND REGULATORY ISSUES

6.1ETHICS APPROVAL

6.2CONSENT

6.3CONFIDENTIALITY

6.4SPONSOR

6.5FUNDING

6.6MONITORING

7PUBLICATION POLICY

8REFERENCES

9APPENDICES

1.INTRODUCTION

<Insert intro>

1.1BACKGROUND

Usually you should focus on three levels: scientific, clinical and political. You need to ensure that a comprehensive literature search has been completed. Then summarise the key studies and evidence here.

Scientific/clinical background (and references):

  • Where has the problem or focus of interest come from?
  • Any observations from your own practice/other clinicians?
  • What is the problem/focus? (disease particulars, incidence, impact on resources/NHS, current best practice)

Political background (and references):

  • DoH policies, NICE guidance etc.
  • What specific gap/s in the evidence are you trying to fill?
  • Do not make any key statements without explanation and evidential back-up (appropriate referencing whenever possible)

1.2RATIONALE

  • Based on all the preceding discussion, what is the precise focus of your study / research question?
  • Hypothesis, where relevant
  • Why this study is important and what problems will it attempt to solve? (this may be a focused summary of key issues identified in Background)

2. STUDY OBJECTIVES

The objectives should be a logical extension of the previous discussion in introduction. They should not suddenly appear as ‘new’ information.

2.1 PRIMARY OBJECTIVE/S

2.2 SECONDARY OBJECTIVE/S

2.3 STUDY OUTCOME MEASURES - What specific outcome measures would help to answer your research questions (e.g. improvement in blood pressure scores)?

3. Study Design

3.1 STUDY METHODOLOGY

  • Clinical trial – Is this an RCT? Is this also a CTIMP?
  • Experimental design (non-clinical trial)?
  • Observational?
  • Cohort?
  • Case control?
  • Qualitative?
  • Multi-method – a hybrid of quantitative and qualitative?

(justification for this approach in light of the research question)

3.2 SPECIFIC METHODS

e.g. Questionnaires, quality of life tools, clinical measurements (e.g. blood pressure), semi-structured interviews

Each method should be fully described and justified in terms of which study objective/s and/or study outcome measures (above) it will address

Methods validated in this patient population, or at least validated generically, should be used where possible (e.g. validated quality of life tools, standard clinical measurements, needs-assessment)

Certain methods not already published/validated, such as questionnaires, may require a small pilot study before the main study

Assessment and follow up involved?

3.3SETTING AND TIMESCALE

Duration of study

Timelines

Location for research related activities.

THIS SECTION SHOULD INCLUDE A TABLE OF CLINICAL AND NON CLINCAL PROCEDURES AND RELEVANT TIME POINTS

4. PARTICIPANTS AND RECRUITMENT

4.1 Groups

Describe which groups will be compared and provide full justification for choosing these groups

4.2 Inclusion criteria

What criteria (specific characteristics) would enable you to include the ‘right’ participants in this study? (e.g. age, specific disease, disease severity, disease measurements)

4.3 Exclusion criteria

What criteria (specific characteristics) are required to determine which participants should be excluded? (e.g. those with co-morbidities which may confound your results, those with mental incapacity)

4.4 Withdrawal criteria

Describe procedures for stopping the study early. Who will decide this and what process will be undertaken to decide this?

4.5 Recruitment

When and where will recruitment take place? Who will be making the first contact? How will you ensure participants provide written informed consent? How long will participants have to decide? Who will recruit and are they qualified to do so, including having up-to-date research training?

When will the methods be used? Who will undertake them and are they trained and/or experienced enough to do so? Describe all practical processes involved in a logical flow. A flowchart is often used to illustrate the overall study process in simpler form

Please note: All investigators, at what ever level, must have appropriate and up-to-date research training before embarking on any research study. It is the responsibility of the CI to ensure any researchers (this includes junior doctors, nurses etc.) working on their study are trained appropriately. They should also ensure that all investigators are fully informed of the specific processes and requirements for this particular study.

4.6 Sample size

4.6.1 Sampling frame

Where will you go to get the fullest possible list of ‘eligible’ participants to sample from (be aware of Data Protection Act)

4.6.2 Sampling method

What sampling method will you use (e.g. ‘random’ sampling for quantitative research; ‘purposive’ sampling for qualitative research) and how will you do this?

Clinical trial: How will randomisation take place?

Sample size calculation (SSC) for quantitative research:

A sample size calculation provides you with an estimate of the number of participants required to minimise ‘errors’ in your final results (often referred to as Type 1 and Type 2 errors)

A mathematical formula is used, but it is the task of the researcher/clinician to first provide some information: i.e.

  • What is your key outcome of interest? The main thing you wish to measure?
  • What difference (e.g. between groups; between before and after) would you regard as being clinically relevant, as based on published evidence (or where this is absent, the best evidence you can decipher – e.g. pilot data, clinical opinion)
  • This may, for example, be an improvement in a mean score of 4 points on a quality of life scale (1-10) – you should also try to determine the relevant standard deviation
  • Then you need to decide on what ‘power’ you wish the study to be – usually we choose 80% power for most clinical studies – this may be even higher for certain clinical trials
  • Then you need to set the significance level (p value), where you would regard any effects as being statistically significant – usually a level of 0.05 is used. Clinical trials often require lower significance levels (e.g. 0.01, 0.001)
  • This information is then used in the SSC
  • For all studies, you should consult a statistician in this process
  • All clinical trials must have formal statistical input from a statistician

5STATISTICS AND DATA ANALYSIS

[Statistical plan]

Data and all appropriate documentation will be stored for a minimum of 5 years after the completion of the study, including the follow-up period.

6ETHICAL CONSIDERATIONS and REGULATORY ISSUES

6.1ETHICS APPROVAL

This study cannot commence without ethics approval from the applicable National Research Ethics Committee. It must be submitted to participating Trust for Site Specific Assessment (SSA). The study will be conducted in accordance with the research governance framework, EU and UK legislations and applicable UK acts.

6.2CONSENT

Consent to enter the study must be sought from each participant only after a full explanation has been given, an information leaflet offered and time allowed for consideration. Signed participant consent should be obtained. The right of the participant to refuse to participate without giving reasons must be respected. After the participant has entered the study the clinician remains free to give alternative treatment to that specified in the protocol at any stage if he/she feels it is in the participant’s best interest, but the reasons for doing so should be recorded. In these cases the participants remain within the study for the purposes of follow-up and data analysis. All participants are free to withdraw at any time from the protocol treatment without giving reasons and without prejudicing further treatment.

6.3CONFIDENTIALITY

The Chief Investigator will preserve the confidentiality of participants taking part in the study in line with the Data Protection Act 1998.

6.4SPONSOR

[Who will act as sponsor - main responsibility for project?, should match the listed sponsor on page 2] This section should include indemnity arrangements from sponsor.

6.5FUNDING & COSTS

xxx are funding this study. [Any per participant payments, investigator payments should be detailed here, plus full breakdown of costs]

6.6MONITORING

Sponsor and other regulatory bodies to ensure adherence to GCP and the NHS Research Governance Framework for Health and Social Care (2nd edition).

7PUBLICATION POLICY

[The study's publication policy should be described in full]

8REFERENCES

[List of useful and relevant references for the study]

9Appendices