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Name of study

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].

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Name of study

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  1. Template for study specific training for Intrapartum Research Studies[ Please see guide before using this]

  2. Name of study Study specific

  3. Contact information • Chief Investigator • Principal Investigator • Trial Midwife • Trial Office [enter study specific contact details]

  4. Background/evidence Study specific

  5. Purpose of study, study design and sample size Study specific

  6. Outcomes – primary and secondary Study specific

  7. 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?

  8. Good Clinical Practice (GCP) • 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

  9. GCP: your responsibilities • 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)

  10. Inclusion/exclusion criteria Study specific

  11. 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

  12. Models of timing of information and consent – Model B For conditions with suspected occurrence risk of 1 in 10 to 1 in 100 (FBS, sphincter injury, delay in labour) Providing full trial information to all women may risk 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

  13. 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

  14. Quick questions! • What are the inclusion criteria? • When do women get information about this study? • What are your responsibilities regarding GCP?

  15. What is informed consent? • A process by which a woman voluntarilyconfirms 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

  16. 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

  17. 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

  18. 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 presentto support her

  19. 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

  20. 6 Point Checklist

  21. 6 Point Checklist

  22. The Consent Form • 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 specific consent form

  23. 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

  24. Study specific flow diagram If appropriate a study specific flow diagram of the consent and randomisation process may be helpful

  25. 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

  26. Trial-Specific AE / SAE reporting • Trial specific AE and SAE reporting info

  27. 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?

  28. 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]

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