Template for study specific training

for

Intrapartum Research Studies

[ Please see guide before using this]

Name of study

Study specific

Contact information

• Chief Investigator

• Principal Investigator

• Trial Midwife

• Trial Office

[enter study specific contact details]

Background/evidence

Study specific

Purpose of study, study design and sample size

Study specific

Outcomes – primary and secondary

Study specific

Quick questions!

• Does the evidence suggest…

• How many trials evaluated…

• What is the study design?

• How many centres are taking part in the study?

• How many women are we hoping to recruit?

• These are the fundamental standards that underpin all clinical research to ensure the:– safety and integrity of research participants– quality of the data

• This study must be conducted in compliance with the protocol which has been approved by the Research Ethics Committee and your R&D dept.

• Handout of the 14 principles of GCP. Further training & information available: http://www.crncc.nihr.ac.uk/NR/exeres/A0BC4FF9-DB82-4B76-BB48-1B715BAC29D1

Good Clinical Practice (GCP)

• Everyone involved in research has responsibility to ensure the safety and wellbeing of research participants

• You must have suitable training and experience to perform the research tasks delegated to you

• It is your professional responsibility to follow GCP standards and keep to the protocol and complete the required data collection forms(or inform your study midwife / PI if you are unable to do so)

GCP: your responsibilities

Inclusion/exclusion criteria

Study specific

Models of timing of information and consent – Model A

For conditions with a suspected risk of occurrence of 1 in 1 to 1 in 10 (partograms, operative vaginal birth, perineal trauma)

Significant numbers of women eligible• Full study information made available during the

antenatal period• Consideration given to obtaining consent before

labour and re-affirming consent when woman eligible

Models of timing of information and consent – Model B

For conditions with suspected occurrence risk of 1in 10 to 1 in 100 (FBS, sphincter injury, delay inlabour)Providing full trial information to all women mayrisk overburdening pregnant women• Initial outline information provided for all women with

access to full information• Full information given when woman becomes eligible,

which may involve prior discussion with the team caring for the woman

Models of timing of information and consent – Model C

For conditions with suspected occurrence risk of less that 1 in 100 (shoulder dystocia)

Consideration should be given to avoiding unnecessary stress for something that is rare

• Appropriate to provide information when the woman becomes eligible

Quick questions!

• What are the inclusion criteria?

• When do women get information about this study?

• What are your responsibilities regarding GCP?

What is informed consent?• A process by which a woman voluntarily confirms

her willingness to participate in a research study after having being informed of all aspects of the study that are relevant to their decision to participate.

• It should only be obtained if the individual has been informed about what the study entails and of any potential benefits and risks of taking part

• Informed consent must be documented by means of a written, signed and dated consent form

Consent: who?• A healthcare professional that has experience of

consent and who has been trained by the [study XXXX] midwife

• They must be familiar with the study (eligibility, aims, procedures, potential risks and benefits) and also be knowledgeable of the alternative options

• They must sign the training log located in the Site file

Consent: when?

• Trial specific info on when this should happen

If a drug trial (CTIMP) eligibility must be confirmed by a doctor before consent is taken by a midwife in accordance with the protocol

Consent: important points to consider

• Use language that the woman understands, free from technical or medical terms – might find ‘Phrases to approach women’ helpful

• Paced information to aid understanding, as the woman may be in pain or distressed

• As far as possible make sure the woman’s birth partner is present to support her

Consent: important points to consider

• Ensure the woman can demonstrate her understanding

• The woman must have time to think and discuss her options with her midwife (or other HCP) and anyone supporting her at that time

• Answer all of her questions, if unsure seek advice from the [study] midwife or doctor

6 Point Checklist

1

•Have you checked that the woman is eligible for the study? [inclusion & exclusion criteria +/- Obstetrician confirmation (CTIMP)]

2

•Have you explained and has the woman understood the aim of the study & what it entails with adequate time to ask questions?

3

•Have you given the woman an opportunity to read the participant information leaflet ?

6 Point Checklist

4

•Have you explained what xxxxxx [e.g. randomisation / placebo] means, and that they will only be entered if xxxxxxxxxxxx?

5

•Have you explained the potential risks and benefits of the study?

6

•Have you explained that the woman is free to withdraw at any time without having to give a reason and without her care being affected?

• Ensure the woman initials each box and does not tick them

• Both the midwife taking consent and the woman must print their name, date and sign the form

• 1 copy is for the woman, 1 for the medical notes and 1 for the site file

Study specifi

c consent fo

rm

The Consent Form

After consent

• Trial specific instructions on how to randomise the woman (if applicable)

• Make sure you follow the protocol and procedures and complete the appropriate data collection forms

• Document in medical notes (consent & study specific procedures / data)

• Ongoing safety monitoring / reporting

Study specific flow diagram

If appropriate a study specific flow diagram of the consent and randomisation process may be

helpful

Safety Reporting for mother and baby

• Adverse event (AE): report as per protocol

• Serious (SAE) if it fulfils standard criteria (irrespective of cause):• Death or life threatening• Persistent or significant disability• Congenital anomaly / birth defect• In-pt hospitalisation or prolongs hospitalisation

• Always report regardless of cause

Trial-Specific AE / SAE reporting

• Trial specific AE and SAE reporting info

Quick questions!

• Who can take informed consent for the xxx study?

• Should all women be approached in labour?

• If a woman is very distressed or unsure should she be recruited?

• Who should you contact about safety reporting?

Who to contact?

If any of these occur or you have any queries contact:

• The Principal Investigator

• Trial Midwife

• Trial Office

[enter study specific contact details]