Collaborators' Intranet
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Welcome to the WOMAN trial collaborators' intranet where you will find useful materials to help you with running the trial in your hospital. More features will be added as the trial progresses e.g. a facility to upload data forms.

GCP training

The WOMAN trial is being conducted under good clinical practice (GCP) guidelines.

As an investigator in this trial you must complete the GCP training programme, unless you have a recent GCP training certificate. To get a certificate of GCP Training, please complete the quiz at the end of the training programme. Also anyone with delegated responsibilities (randomisation, data collection, administration of the trial treatment) for the WOMAN trial should complete the training.

The complete ICH GCP Guidelines can be viewed here.

WOMAN trial training films

The following films can be viewed on any web based viewing application e.g. Windows media player, VLC media player, Nero showtime, Power DVD etc. Some applications are freely downloadable from the internet.

TRIAL PROCEDURES - high resolution (103MB) - low resolution (43MB)

PROTOCOL DISCUSSION - high resolution (49MB) - low resolution (25MB)

PLEASE NOTE - Depending on the capacity of your computer these films may take a while to download, but once downloaded you can then save the files into your hard drive. A DVD with both films will be provided with the Investigator's Study File when you join the trial.

Presentations
When opening the files, if you are asked to type in the username and password again, please click on CANCEL and the file should open.

Prevention and Treatment of Postpartum Haemorrhage

Scientific background

How to ensure the trial is conducted properly at your hospital

How to maintain your Study File

GCP test guidance

How to assess eligibility

How to complete the entry form

How to obtain consent

How to randomise an eligible woman

How to manage and administer the trial treatment

How to complete the outcome form

How to send data electronically

How to submit data online

What to do if a woman develops an unexpected problem

Reporting adverse events