Toolkit... · Web viewThe toolkit promotes an awareness of Good Clinical ... Log’ in accordance with Sponsor and/or site Standard Operating Procedures ... Care Pathway (showing

A Toolkit for Intrapartum Research Study-Specific Training

Introduction These materials aim to support the delivery of high quality study specific training to meet the needs of experienced clinical staff who will contribute to the conduct of a study at site during their routine clinical practice. This supports a pragmatic and proportionate approach to research governance enabling research to become embedded in clinical practice.

The toolkit promotes an awareness of Good Clinical Practice (GCP), in particular consent and safety procedures, whilst acknowledging that training should be proportionate and tailored to the role of the clinician in the study. It does not replace the need for more detailed GCP training as applicable to Principal Investigators or study specific clinicians within a site - those who will always be identified on the ‘Delegation of duties’ log.

Chief Investigators (CIs) and Principal Investigators (PIs) need to consider the duties and tasks that may be undertaken by clinical staff during routine intrapartum care (e.g. checking eligibility, receiving consent as part of an ongoing process, study specific interventions or data collection) and use this toolkit to provide appropriate study specific training in accordance with the principles of GCP. Training can be documented on either a stand-alone ‘Training Log’ or as part of the ‘Delegation of Duties Log’ in accordance with Sponsor and/or site Standard Operating Procedures (SOP). A Note to File detailing the study specific tasks which this training will enable clinicians to undertake, together with a copy of the training materials, should be included in the Site File. Templates are provided in this toolkit. It is important that a training log is maintained in order to identify which clinical staff have received training and therefore are able to undertake these predefined study specific tasks should the opportunity arise. This will also enable appropriate monitoring of this by the Sponsor (e.g. Trial office).

Acknowledgements

These materials have been developed by the RCOG Intrapartum Clinical Study Group and NIHR GCP facilitators based in Birmingham and evolved from materials produced and delivered by the HOLDS study team.

We would like to acknowledge and thank all who have contributed to the materials to enable the successful development of this toolkit. This is the first version and we would welcome constructive comments – please email them to [email protected].

1 Version 1 July 2012

mailto:[email protected]

MaterialsIt is anticipated that this toolkit will be used by Intrapartum Research Teams (i.e. CI / CTUs / Sponsor) to devise study-specific training which will combine a slide presentation with discussion, and be supported by study-specific reference materials (Training File) at site. This Guide supports the use of the template slide presentation and template study-specific training materials. It is anticipated that this will be developed by the CI and Trial Office, in consultation with collaborators, for use in the study sites, and should not be altered by sites.

The toolkit includes: 28 Slides (PowerPoint presentation template into which study-specific information can be

added) Guidance Notes to support the use of the slide template (p3-17) Template Training File (word document template for study specific reference materials)

which includes:• Suggested Contents (p19)• Template training Log (p20)• Template ‘Note to file’ (p21)• Template Contact Information Sheet (p22)• Template ‘Suggested phrases for recruitment’(p23)• Template ‘FAQs for participants and clinicians’ (p26)


Guidance Notes for use of the slide presentation template

Slide 1

This presentation template should be used by Chief Investigators (CIs) and their study coordinating team as the basis to develop a study-specific slide presentation. If used in full, the presentation template promotes an awareness of GCP, in particular consent and safety procedures, whilst acknowledging that training should be proportionate and tailored to the role of the clinician in the study. It does not replace the need for more detailed GCP training as applicable to Principal Investigators or study specific clinicians within a site - those who will be identified on the ‘Delegation of duties’ log.

CIs and PIs (as applicable) need to consider the duties and tasks that will be undertaken by clinical staff during routine intrapartum care (e.g. checking eligibility, receiving consent as part of an ongoing process, study specific interventions or data collection) and tailor the study-specific content of the slides to meet these training needs.

It is advisable to provide this training in small groups (max 10 – 12 people) in order to promote discussion, and use the study-specific training file to provide examples of all the trial specific documentation and data collection forms and promote its use at site. Handouts of the slide presentation and the 14 principles of GCP (p16) should also be provided to attendees for reference.


Slide 2

Clarify objectives of training and identify what the staff attending are / are not expected to be able to do once training is completed with regard to study activities. This may include for example:- Overview of XXX study (including funder)- Identify eligibility criteria for XXX study- Understand the process for receiving consent for XXX study- Recognise your role in data collection - Recognise your role in monitoring safety of study participants……etc

Slide 3

Enter study specific details


Slide 4

Enter study specific details (although you may need to add extra slides to accommodate study-specific details, it is preferable to keep this information relatively short and to the point!)

Slide 5

Enter study specific details – keep it simple and to the point.


Slide 6

Insert study specific details

Slide 7

These quick questions are designed to encourage interaction and make sure the clinicians have understood the trial and its processes. It is useful to use them as an opportunity to summarise the key points before moving on. Amend them according to the information that you have presented.


Slide 8

This introduces the fundamental principles of GCP and allows you to prompt staff to attend further training where appropriate (e.g. for the study specific research staff). PI can advise about local access.

Slide 9

It is vital to ensure that participants understand that by undertaking this training, and signing the Training Log, they are accepting their responsibility to ensure the safety and wellbeing of research participants.

This is an opportunity to reinforce that as in clinical practice, you should not undertake a task for which you are not trained, familiar and suitably prepared. Remind those you are training where they can seek additional information (e.g. from study specific personnel or the training file).


Slide 10

Insert study specific details


Slide 11 or Slide 12 or Slide 13

Three slide templates based on the RCOG good practice framework for researchers (Clinical Governance Advice 6a: http://www.rcog.org.uk/files/rcog-corp/CGAObtainingConsentResearchLabour0810.pdf are provided. Researchers should identify the model appropriate to their study and delete the other two slides:

Slide 11: Model A

Slide 12: Model B

Slide 13: Model C


http://www.rcog.org.uk/files/rcog-corp/CGAObtainingConsentResearchLabour0810.pdf

Slide 14

These quick questions are designed to encourage interaction and make sure the clinicians have understood the trial and its processes. It is useful to use them as an opportunity to summarise the key points before moving on. You may wish to amend them according to the information that you have presented.

Slide 15

Consent is a process and it is anticipated that study specific personnel (i.e. the PI and members of the research team at site) will always have a role in this, even if they do not obtain the written signature. This slide should be included to raise awareness of the consent process even if clinical staff are not going to be involved in receiving consent themselves.


Slide 16

This provides an overview of the study-specific process where clinical staff are going to be involved in receiving consent in accordance with the protocol. This is not sufficient training to prepare clinical staff to receive informed consent for the research study unless they currently obtain consent during intrapartum care as part of their routine clinical practice. It is acknowledged that midwives are autonomous practitioners and routinely take consent for clinical procedures. However, this material may not be sufficient for junior doctors or less experienced clinicians.

Slide 17

It may be useful to provide details of the trial specific timelines of when consent should be obtained and whether it is in planned, urgent or emergency circumstances. The study specific process should also be included (for example the need to check eligibility criteria and by whom this should be done, prior to seeking and receiving consent).


Slide 18

It is important to consider the timeframe you have when the woman becomes eligible - it might be appropriate to produce a summary of the PIL (with approval from the Research Ethics Committee) to aid information giving and promote opportunities for recruitment. A template ‘Phrases to approach women’ is provided in the Toolkit (p20).

Slide 19

Evidence suggests that women find the written information and verbal explanations from clinicians very helpful particularly with the birth partner present. Use this as an opportunity to discuss how the requirement for a ‘prior interview’ (time to think) can be met in the context of the study.


Slide 20

This is a useful summary of the key points in the consent process prior to signing the consent form.

Slide 21

Point 4 should be amended to meet study specific requirements – e.g. it may include randomisation, blinding or specific inclusion/exclusion criteria.


Slide 22

Use this as an opportunity to show clinicians the study consent form and how to complete it (as applicable). The woman herself must sign the consent form and all parts must be completed. The points included in this slide are best practice; you may wish to amend them according to the requirements of the protocol.

Slide 23

Additional information may need to added to this slide according to the roles/tasks to be undertaken after consent has been obtained. Documentation in the medical notes must include signing and printing name, designation, PIN (if appropriate) and date and time.


Slide 24

Flow diagram should show study specific tasks, whatever they are. Additional slides may be added.

Slide 25

Use this as an opportunity to emphasise the fundamental importance of monitoring safety of mother and baby and of reporting safety events irrespective of cause. Remind clinicians that if they are unsure what or how to report safety events the PI, members of the site study team or CI can provide guidance.


Slide 26

Insert study-specific safety reporting procedures / information and it might be helpful to state where forms are kept.

Slide 27

These questions are designed to facilitate discussion within the group. They can be used to explore any queries or concerns about when to approach women and to reassure clinicians that if a woman is unsure or distressed it is fine not to recruit them.


Slide 28

Insert study specific contact details to reinforce previous contact information.

Acknowledgements

These materials have been developed by the RCOG Intrapartum Clinical Study Group and NIHR GCP facilitators based in Birmingham and evolved from materials produced and delivered by the HOLDS study team. The Development Group would like to acknowledge and thank all who have contributed to the materials to enable the successful development of this toolkit.

Development Group

Sara Kenyon, Senior Lecturer, Lucy Ingram, Research Midwife and Sophie Dann, Theme Co-ordinator, School of Health and Population Sciences, University of Birmingham

Hannah Reay, Lead Research Nurse, Birmingham & the Black Country CLRN

Jackie Sears, Lead Nurse, Pan Birmingham Cancer Research Network on behalf of the Birmingham region Research Training Collaborative (BRTC)

Reviewers

Annette Briley, Consultant Midwife/Clinical Trial Manager King's College, London

Barbara Farrell, Trial Director, CORONIS and INIS Trials, NPEU, Oxford

Margaret Grant, Unit Co-ordinator, Birmingham Clinical Trials Unit

Karen Hampshire, Lead RM&G Manager, Birmingham and the Black Country CLRN

The trial staff of the INFANT and BUMPES Trials from UCL, London


14 Principles of GCP

1. The rights, safety and well-being of the trial subjects shall prevail over the interests of science and society.

2. Each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks.

3. Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects.

4. The necessary procedures to secure the quality of every aspect of the trial shall be complied with.

5. The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.

6. Clinical trials shall be conducted in accordance with the principles of the Declaration of Helsinki.

7. The protocol shall provide for the definition of inclusion and exclusion of subjects participating in a clinical trial, monitoring and publication policy.

8. The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting a clinical trial.

9. All clinical information shall be recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected.

10. Before the trial is initiated, foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A trial should be initiated and continued only if the anticipated benefits justify the risks.

11. The medical care given to, and medical decisions made on behalf of, subjects shall always be the responsibility of an appropriately qualified doctor or, when appropriate, of a qualified dentist.

12. A trial shall be initiated only if an ethics committee and the licensing authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored.

13. The rights of each subject to physical and mental integrity, to privacy and to the protection of the data concerning him in accordance with the Data Protection Act 1998 are safeguarded.

14. Provision has been made for insurance or indemnity to cover the liability of the

investigator and sponsor which may arise in relation to the clinical trial.


Training File Contents

Training Log

Contact Information (Principal Investigator, Study Midwife, Trial Office, etc)

Participant Information Leaflet

Summary Participant Information Leaflet

Blank & Dummy Consent Form

Blank & Dummy Data Collection Form/s (think about how you might present these for clinicians, ie. in a pack with a pen)

Copy of Study-Specific Training Sides (adapted for your study)

Suggested Phrases for Recruitment

Flowchart of Care Pathway (showing inclusion/exclusion criteria)

FAQs by Participants

FAQs by Clinicians

RCOG Clinical Governance Advice 6a (Obtaining Valid Consent to Participate in Research While in Labour) – for the latest version, please see www.rcog.org.uk/obtaining-valid-consent-participate-research-while-labour


http://www.rcog.org.uk/obtaining-valid-consent-participate-research-while-labour

http://www.rcog.org.uk/obtaining-valid-consent-participate-research-while-labour

Training Log

Study Title:

Site:

Principal Investigator:

Study Midwife:

Objectives of Training (list study specific tasks or duties)

Name (Print) Job Title (Print) Signature Date


Note to File

Training will be provided for clinical staff to undertake the following pre-defined tasks (please list below)

A copy of the training materials is in the site file.

Study: Principal Investigator (print name):

Date: Principal Investigator Signature:


[Study Title] Contact Information

CONTACT DETAILS FOR STUDY SITE

[Hospital address]

Principal Investigator: [Name], [Telephone]

Trial Midwife: [Name], [Telephone]

Trial Co-ordinator: [Name], [Telephone]

Email: [E-mail]

Website: [Website]

TRIAL REFERENCE INFORMATION

Sponsor: XXXXX

Sponsor's protocol code: XXXXX

CTA number: XXXXX

Main REC ref. number: XXXXX

EudraCT number: XXXXX

ISRCTN: XXXXX


Suggested Phrases for Recruitment

These are suggested phrases to help you recruit women to your study.

Good practice to improve your study specific phrases would be to circulate your draft to a group of clinicians in the relevant field, ask them to give feedback and suggest changes. Amendments might also be made after it has been in use.

--------------------------------------------------------------------------------------------------------------------------

Suggested phrases for discussing (name of study) with women

What is (study name)?

• “We are involved in a study called (study acronym or title), this means (explanation of acronym) and it is looking at (research question).

• Remind the woman that she may have already received some information about the study (depends on when study information was intended to be given)“You may remember getting some information about this study when you were pregnant?”

• Explain why the study is being carried out“We don’t know what dose of drug X is best for women in your situation so this study is going to try and find this out” or “As we don’t know which method/drug dose/procedure is better, we are going to compare them with each other”.

• Describe possible effects of the intervention being tested“The drug may reduce/increase the amount of blood you lose after you give birth”.

• Describe terms like ‘randomisation’ (or other relevant study methods)“So we can compare what happens as fairly as possible women are put into groups. Which study group you get put in will be decided by chance (randomly) by a computer. This means we can then compare the groups fairly to see which is better for woman and baby”.

• If CTIMP explain blinding of clinician“I won’t know which drug/dose you will receive but we can find that out if we need to”.


• Reassure the woman that she will be appropriately monitored for any possible side effects (specify if this is part of the routine care she would receive outside of the study or if this would be in addition because she is participating in the study) “Both you and your baby will be monitored more closely if you agree to take part; this will mean the baby’s heart rate will be continuously monitored” or “If you agree to take part we will continue to care for and monitor both you and your baby appropriately”.

• Explain all that is involved for follow-up care e.g. Interviews, questionnaire/s, further testing outside of standard care up until the last study data collection point“As part of the study we will send you a questionnaire when your baby is XX old, asking you about how you feel, how often you visited your doctor, how well your baby is”.

• Explain that participation is completely voluntary“Deciding whether you take part in this study is completely up to you. If you do decide to take part you can stop taking part at any time, without giving a reason, and this will not affect the standard of care you receive”.

• Ask if there are any questions“Is there anything you would like to ask now, or is there anything you would like me to explain again?”

• Provide study information leaflet allow enough time to read & comprehend (summary leaflet may be more appropriate especially if time is limited due to the nature of the intervention/study)

• Encourage questions, allow adequate time to answer

• Explain what happens next (consent, enter the study etc)

• Thank the woman and partner for listening to you


FAQs by ParticipantExamples – adapt with study-specific information

Do I have to join the trial?No, you don’t have to. If you do join the trial you would be helping us find out the answer to an important question. We hope that this trial will tell us whether women in the similar situations as you would benefit from...

Can I change my mind if I join?Of course. You can change your mind at any point and the standard of your care you receive from health professionals will not be affected.

Will you keep all my information confidential?Yes. All your information is kept securely and only seen by those in the research team who need to see it. Your information will not be passed on and we will not use your name or personal details to identify you in our reports.

Why do you think I should join?It isn’t up to anyone else to decide if you should join, but you have been asked because…

What are the benefits for me?We can’t guarantee that you will benefit from taking part but we are sure that in taking part you are helping answer an important question…

What will I have to do?

What information are you collecting about me and my baby?

How long will my information be kept for?XX years. This will be kept safely and securely, it will not be used again for any other purposes.

Where will my information be kept? / Will my information be kept confidential?Yes, all of your information is confidential. Only those who need to see it will. The computers it is kept on when it is being used are secure and password protected. Only those who need to see it will have a password too. It will be kept in a locked cabinet, in a locked room and there will only be couple of members of research staff that will be allowed access to your information. It will only be used to help us with this research.

Other Trial-Specific Questions…


FAQs by CliniciansExamples – adapt with study-specific information

Why are only women with [eligibility criteria] eligible for this trial?

Can I recruit women with [excluded criteria]?No.

Are women who have had a miscarriage or termination eligible?

Why are women randomised?By randomising (allocation by chance) women there will be an equal split of characteristics between the different arms. This means that we will be able to say that any difference in the groups is down to the intervention and no other factor. If we didn’t randomise then characteristics would be unfairly represented in one of the groups.

If the woman is allocated to the [intervention] group, what should I do?

If the woman is allocated to the [non-intervention] group, what should I do?Just continue to provide the same care you would normally, there is nothing extra for you to do.

Who can I contact with a question?

What if a woman has a question I cannot answer?

How can I refer a woman for the trial?

What do I have to do after I have referred a woman?

What difference in the mothers and babies are you looking for (outcomes)?

How many women are needed?

How long will this take?

What’s in it for me?This is an excellent opportunity to expand your knowledge of research, even if you are not a [trial] midwife. The [trial] midwives will be working with leading maternal health researchers. The training you all receive will be fun but it will also be beneficial and can be added to your PREP portfolio. There will be competitions between teams and Trusts with prizes chosen by you for the best referrers and recruiters.


Documents

Toolkit... · Web viewThe toolkit promotes an awareness of Good Clinical ... Log’ in accordance with Sponsor and/or site Standard Operating Procedures ... Care Pathway (showing