PREDICT Project Endorsement Process

1. Initiate project review by the PREDICT Executive

All projects (including surveys and pilot studies) to be carried out with PREDICT endorsement must first be submitted to the PREDICT Executive for review and approval. Please read through the requirements of PREDICT endorsed studies first to determine eligibility and to gain an understanding of expectations. We will only endorse projects that meet our criteria.

• IF YOU ARE NOT A PREDICT MEMBER and are wanting to have a study endorsed that has been developed with an external group or network, please email your protocol and other relevant documents to the Network Co-ordinator with a cover email explaining the study status and why you are seeking PREDICT endorsement (see 2) at this stage. Please outline any contact undertaken with PREDICT Executive members during the development of your project. Please also complete our 2 page Project Summary template.
  NB. This includes both surveys and pilot studies.
  All material will be regarded as confidential.

• IF YOU ARE A PREDICT MEMBER and have a new project idea, please complete our 2 page Project Summary template (insert link) and email this to the Network Co-ordinator along with a cover email explaining why you are seeking PREDICT endorsement. Please outline any contact undertaken with PREDICT Executive members during the development of your project idea. It is our preference to receive projects early in development so that they can be developed collaboratively with the network.
  NB. This includes both surveys and pilot studies.
  All material will be regarded as confidential.

2. Contact the PREDICT Network Co-ordinator to schedule review

• Contact the PREDICT Network Co-ordinator at: predict@mcri.edu.au or ph. 03 9486 6081, at least two weeks in advance to have your project review scheduled at an Executive meeting, please see current dates below.
• Surveys will need to be scheduled some time prior to the targeted release to avoid overlap of surveys in circulation as well as avoid survey fatigue of our members. See the Clinician Survey Schedule below re available times.
• Rarely, projects may, in extraordinary situations, be reviewed by the executive via email outside of meeting cycle. However, this will only occur due to urgent evolving clinical need.

3. Review feedback from the PREDICT Executive

• Approximately 2 weeks following the meeting, you will receive a letter from the Executive advising if your project:

  – is endorsed, or
  – requires further consideration subject to provision of further information, or,
  – is declined.

  We aim to provide as much feedback as possible for a transparent process. Please note, we do not have capacity to provide a badge of support if the project does not meet our criteria even if we believe it to be worthwhile.  If your project is endorsed the letter will also include advice on PREDICT expectations and we ask you to sign the letter, scan and email it back to confirm your agreement.

4. Eligibility for PREDICT endorsement

• Projects must involve the Emergency Department
  The PREDICT network exists for research involving Emergency Department clinicians, hence projects that we endorse must involve the ED and our emergency clinicians to a considerable degree. It is the expectation that the PREDICT network is involved early in the study development prior to formation of protocol and funding applications.
• Projects must be multi-centre
  A PREDICT study must involve more than one centre. However, as few as two centres working collaboratively could constitute a PREDICT study.
• Projects must align with other PREDICT projects
  We will not endorse projects where doing so will compromise another PREDICT project without a clear plan from both project teams that this is acceptable.
• A pilot study submitted with full protocol, must provide the opportunity for considerable PREDICT involvement in protocol development post endorsement (not merely provision of sites), or it will not be endorsed. We wish to have full involvement in any pilot studies seeking PREDICT endorsement from a very early stage. In those studies where this is not possible, and a pilot is being undertaken with the idea that PREDICT is involved in the main study, we encourage early application for endorsement of the main study, as soon as it is apparent that the pilot study will advance to a larger multi-centre study.
• International studies with full protocol that have already been commenced overseas and now wish to involve ANZ sites within PREDICT, will be considered on a case-by-case basis providing they meet other criteria for endorsement.

5. Expectations for PREDICT endorsed projects

• Formation of a Study Steering Group
  Once approval is obtained, if there is not already a study steering group, please organise one as soon as possible to facilitate collaborative development of the study protocol and ongoing management support. See our guidelines on developing a Steering Group.
  Two members of the steering group should be PREDICT members (one will be your PREDICT Executive contact as explained below).  The steering group member should include a research nurse/assistant. The Executive Committee should be advised of all members of the Steering Group as soon as this is organised.  

• Regular reporting to the PREDICT Executive and Membership
  One of the Executive Committee members, will be nominated upon approval to be your contact person for ongoing communication with the PREDICT Executive.

  The contact person should be provided with a progress report for scheduled quarterly full day Executive Committee meetings (see above schedule).  The contact person will present this report and advise the Study Steering Group of any suggestions from the PREDICT Executive following routine project progress review.  The Executive contact should also be provided with minutes of the Study Steering Group meetings.

  It is also expected that you or your nominated study lead will present on study progress at the annual PREDICT members meeting.  On an annual basis the study lead will also be requested to provide a brief report for inclusion in the monthly PREDICT newsletter.

• Selection of PREDICT sites
  When a study is ready to commence selection of sites, criteria for eligible sites should be developed with the Study Steering Group.  They should then liaise with the Network Co-ordinator regarding an expression of interest form.  The Network Co-ordinator will assist by sending this to the PREDICT membership on your behalf. Members can then respond if they wish to express interest in participating. The decision of which sites are selected will be made by the study steering group. Specific instructions will be given for surveys.

  The site Principal investigators (PIs) participating in PREDICT endorsed studies will all need to (or become) PREDICT members – to facilitate network communication.  Referrals for membership should be directed to the PREDICT Network Co-ordinator.

• Communication across the network
  Research co-ordinators who provide support at the sites involved should be copied into all key communications on the study so they can provide support to the site PIs.

• Publications
  Develop a publication plan at the time of finalising the study protocol that adheres to the PREDICT publication guidelines. Review and update this as needed throughout the study.

  When your results are available, draft journal publications must be reviewed by the PREDICT Executive Chair or designee prior to submission to any journal.  Any media release should also be sent to the Chair or designee prior to release.

• Acknowledgement
  Lead researchers must try to include site investigators as authors in publications as much as possible or spread authorship across a number of papers (where possible). If this is not possible due to journal specifications, always attempt to acknowledge sites/staff in the acknowledgements section of the paper or include the PIs in PubMed as collaborators.  The PREDICT network must also be acknowledged in any media or publication following agreement by the PREDICT Executive and the correct logo must be used. Other options for site staff acknowledgement include:
  – issue certificates to the sites to acknowledge the department.
  – send template letters to groups of staff at sites to personally thank them.
  – offer to present study findings at the sites.

PREDICT – advice for development of a Study Steering Group

Purpose of the Study Steering Group

The purpose of a research Study Steering Group (SSG) is to oversee the research from its development stage through to completion and publication, providing strategic and operational advice to the Co-ordinating Principal Investigator and core research team.  The SG should aim to provide support, guidance, and leverage to give the study an increased chance of success.

Key responsibilities usually include:

• Providing expertise and experience to the design and development of the study protocol.
• Creating an authorship policy prior to the study starting.
• Utilising networks of influence to inform and steer the direction of the study.
• Contributing to decisions about sites to be included.
• Ensuring that the protocol is followed and monitoring recruitment progress.
• Troubleshooting to address problems when they arise.
• Ensuring that the study outputs are delivered.

Who to include

Aim to include a cross section of people with diverse skills, experience and perspective relevant to the research.  The PREDICT Executive can provide advice on potential members to include as required. Consider the following:

• Clinicians with specific interest and expertise in the subject area
• Clinicians and researchers with research design and operations expertise
• A member of the PREDICT Executive (mandatory)
• A further PREDICT member (mandatory)
• A Research Assistant
• Selection of PIs from different hospital settings
• A consumer or end user if relevant to the type of study
• A less experienced early career researcher to mentor NB. When you first set up the group you may not have determined sites so start with who is available and add other members to the group later on if needed.

Structure and size of group

Size and structure of the steering group may vary in relation to its stage of development, the type and complexity of the study, and how many sites are involved. PREDICT does not suggest a rigid structure and as mentioned above, the group can be expanded if needed.

We recommend the following:

• Approximately 5 – 8 members – not too large is usually preferable.
• Appoint a chair (usually the CPI)
• You may want to consider how many members need to be present for key decisions and drafting terms of reference for transparency (more applicable to large complex studies).

Frequency of meetings

Research studies in development often require the SSG to meet more often e.g. 2 weekly until the protocol is developed whilst later during recruitment/data collection less frequent meetings are needed e.g. 2 monthly.  Choose a frequency that is appropriate, given the stage of study development. Review this regularly.

• Plan meeting dates and times several months in advance and ideally send out calendar invitations so that it gets into the diary.
• Ideally send out the agenda 1 week to a few days prior as a reminder but also to allow others to add items to the agenda.
• Schedule a follow up meeting if needed to resolve a complex issue.

Formalities

• Ensure the meetings are minuted to capture the essence of what was discussed, decisions made and actions required.
• Circulate the minutes promptly so that SG members can follow up on actions if needed.
• Try and resolve any concerns or complaints in a timely manner to promote a functional group. The PREDICT Executive is available to give advice if needed.
• It is expected that the SG report to the PREDICT executive four times per year with study progress.