Recruitment and COVID-19

 

Randomisation during COVID-19 pandemic

The STAMPEDE trial will reopen to recruitment on Monday 30th November. Only sites with a greenlight activation email may randomise patients.

The STAMPEDE team continue to work remotely, and the randomisation line will not be used. Therefore please notify us via email (mrcctu.stampede@ucl.ac.uk) that you wish to randomise a patient, providing a named contact and contact phone number, and we will call you back to complete the randomisation. Please ensure that at this stage, the consent is in place and the eligibility checklist and randomisation CRF is completed.

 

Remote consent during COVID-19 pandemic

We understand capacity at sites will be varied and participant attendance could constitute a mixture of on-site visits and remote visits via telephone or video consultation due to the current COVID 19 pandemic. With this in mind, we would like to adopt a flexible approach for taking consent on the trial; consent to the STAMPEDE trial can be taken as follows:

 

Face to face clinics

In-person is the preferred option if face-to-face clinics are planned; an appropriately delegated member of the trial team must take consent. To minimise time spent in clinic the PIS can be sent (via email or post at least 24 hours prior to the visit) and discussed with the participant in advance of the clinic appointment.

Please send the anonymised signed consents forms via secure email or fax, to the MRC CTU as soon as possible

Where it forms part of local policy to manage and reduce the risks associated with COVID-19 the following is allowed:

 

Telephone  & Video consultation

Verbal consent may be taken via a telephone or video consultation provided an appropriately delegated member of the trial team conducts this. If possible, it is recommended a member of staff witness the consultation process and the participant’s verbal consent. The participant must receive the PIS at least 24 hours in advance of the consultation. The whole process should be fully documented in the participant’s medical notes using the “STAMPEDE Remote Consent File Note”, if a witness is used; the name, position, signature of the witness should be added to the file note, and the date of verbal consent provided.

Please use the template file note (found here) to document the consent verification process.

A consent form will need to be fully completed, signed and filed within the participant’s records when the participant next attends clinic.

 

Important notes

The need for full written and signed consent is a legal requirement even if consent is taken verbally initially via video or telephone consultation.  We expect this to be done at the next face-to-face visit the patient attends with the oncology team.

Once the consent form is completed, it should be sent to MRC CTU with a copy of the file note.

Please send signed consents forms and file notes to the MRC CTU via email (Galaxkey secured) or by fax. Please note the STAMPEDE team is currently working remotely we are therefore not accepting consent forms sent by post.

STAMPEDE

Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy

See the latest News in STAMPEDE through the link to the right.