Recruiting a woman

1
Recruiting a woman
2
Recruiting a woman

• 1. Obtain consent from the woman
• 2. Complete the At Study Entry page of the Data
  Collection
• Booklet
• 3. Call the randomisation telephone number
• During the day the Regional Trial Office
  (RTO) will
• do the randomisation using the internet
• During the night you will connect to the
  CORONIS
• automated telephone system
• 4. Take the envelope with the corresponding
  Allocation Number given by the randomisation
  service

3
Informed consent
Consent Form The most important document of
all. This MUST be completed and signed (or
marked) by the woman BEFORE any data are
collected.
4
Allocation envelopes

• Allocation envelopes MUST NOT BE OPENED until the
  telephone call has been made to obtain the
  envelope number for the woman being recruited.
• If an envelope is opened in error you MUST inform
  the RTO staff immediately.

5
At Study Entry
This page MUST be completed before the
randomisation telephone call is made.
6
Allocation Form
The Allocation Form inside the Allocation
Envelope looks like this. The form describes
the procedures to be used for the woman
randomised.

• Study Number 07/0123
• Blunt abdominal entry
• Single layer closure of the uterus
• Non-closure of the
  peritoneum
• All other techniques should
  
• be as routine practice.

• IMPORTANT
• Tick relevant boxes in the Data Collection
• Booklet to show allocation opposite.
• Collect sutures (if applicable).
• Put this Allocation Form in womans notes to
• accompany her to theatre.
• Put up in theatre to ensure correct allocation
• is followed during surgery.
• After surgery put this form in the womans
• Data Collection Booklet.

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At Study Entry
Once you have been given the allocation for the
woman, complete the boxes at the bottom of the
page.
8
Sutures

• The CORONIS suture box (if applicable) is kept
  with the Allocation Envelope box.
• These sutures should ONLY be used for the
  allocated intervention.
• These should ONLY be used for women in the
  CORONIS Trial.

9

• Keep the womans Data Collection Booklet in a
  convenient place, either in her file (notes or
  chart) or on the post-natal ward, so that it can
  be completed at various stages during her
  hospital stay.
• Ensure her name is written clearly on the front
  cover.
• Ensure her study number is written on every page.
• If you have information that you think may be
  relevant and it does not fit in with the
  questions in the booklet write it on the back
  page of the Data Collection Booklet.

10
Immediately After Delivery
This page must be completed for all women,
irrespective of the mode of delivery.
11
Surgical Techniques Used (pages 3 - 5)
Pages 3 5 should be completed by the surgeon
immediately after surgery has been completed.
If for any reason the allocated interventions
were not followed full reasons should be given in
the space provided. All questions must be
completed.
12
Postpartum Hospital Stay (pages 6 9)
This section of the Data Collection Booklet can
be completed daily during the womans stay in
hospital or at discharge from her hospital record.
13

• When completing the Data Collection Booklet
  please remember to
• write CLEARLY using a black pen
• answer ALL the questions
• always complete the STUDY NUMBER on every page
• When pages 3 - 9 of the data Collection Booklet
  have been completed, send the top copies to the
  Regional Trial Office as soon as possible.

14
Serious adverse event (SAE) (2 pages)
Serious Adverse Events are outlined in the
protocol, handbook and in the Data Collection
Booklet. If you have reason to report an SAE,
forms can be found in the Document Box. SAEs
must be reported within 48 hours to the Regional
Trial Office
15

• Procedure for reporting SAEs
• SAEs should be reported to the RTO within 48
  hours of
• the occurrence.
• The RTO will forward all SAEs to the
  International
• Co-ordinating Centre in Oxford.
• The RTO has a standard operating procedure for
• reporting Serious Adverse Events.

16
Six Weeks After Discharge (pages 10 12)

• All woman should be given a Medical Card and a
  six week follow-up appointment at discharge from
  hospital.
• This appointment may be carried out
• At the hospital
• At a local clinic
• At home
• By phone
• Separate Six Weeks After Discharge Forms can be
  found in the Document Box if the woman is being
  followed-up outside the hospital.

17
3 year follow-up

• There are plans to secure funding for 3 year
  follow-up of all women recruited to the trial.
• Ensure all women are told that you will be
  contacting them regularly over the next 3 years.
• Give every woman a Change of Address Card and a
  new Medical Card at her 6 week appointment.

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• When completing the Data Collection Booklet
  please remember to
• write CLEARLY using a black pen
• answer ALL the questions
• always complete the STUDY NUMBER on every page
• Once you have completed pages 10 - 12 of the data
  Collection Booklet, please send the top copies to
  the Regional Trial Office as soon as possible.