FOAM

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. Return both documents to the FOAM Trial Office.

• Co-Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Pharmacy Registration Form [.pdf]
• Principal Investigator Registration Form [.pdf]

Links to the current protocol, Patient Information Sheet(s), Informed Consent Form(s) are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.

Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the FOAM Trial Office. 

• Protocol [.pdf]
• Patient Information Sheet [.pdf]
• Informed Consent Form  [.pdf]

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Document Version Control List. Links to the Document Version Control Lists used in this trial are below in reverse date order.

• Version Control List V9 - Investigator Site File [.pdf]
• Version Control List V8 - Investigator Site File [.pdf]
• Version Control List V7- Investigator Site File [.pdf]
• Version Control List V6 - Investigator Site File [.pdf]
• Version Control List V5 - Investigator Site File [.pdf]
• Version Control List V4 - Investigator Site File [.pdf]
• Version Control List V3 - Investigator Site File [.pdf]
• Version Control List V2 - Investigator Site File [.pdf]
• Version Control List V1 - Investigator Site File [.pdf]
• Version Control List V4 - Pharmacy File [.pdf]
• Version Control List V3 - Pharmacy File [.pdf]
• Version Control List V2- Pharmacy File [.pdf]
• Version Control List V1- Pharmacy File [.pdf]

Amendments

Below is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• Amendment 07, 24 Mar 2016 [opens new page]
• Amendment 06, 09 Sep 2015 [opens new page]
• Amendment 05, 10 Aug 2015 [opens new page]
• Amendment 04, 28 Apr 2015 [opens new page]
• Amendment 03, 20Apr 2015 [opens new page]
• Amendment 02, 27 Feb 2015 [opens new page]
• Amendment 01, 24 Nov 2014 [opens new page]

Case Report Form

• Screening Blood Sample Collection Form [.pdf]
• Randomisation Form [.pdf]
• Baseline Form [.pdf]
• Concomitant Medication Form: Baseline [.pdf] 
• On Treatment Form [.pdf]
• Concomitant Medication Form: On Treatment [.pdf]
• Treatment Discontinuation Form [.pdf]
• Withdrawal of Consent Form [.pdf]
• Deviation Form [.pdf]
• Death Form [.pdf]
• SAE Form [.pdf]

Guidelines

• CRF Completion Guidelines [.pdf]
• SAE Form Completion Guidelines [.pdf]

Other Trial Documents

• Pharmacy Manual [.pdf]
• Laboratory Manual [.pdf]
• Greene Climateric Scale [.pdf]
• On Treatment Sloan Diary [.pdf]
• Screening Sloan Diary [.pdf]
• Utian QoL Scale [.pdf]
• SPC Folic Acid [.pdf]
• Patient Booklet [.pdf]

Newsletters

• Newsletter - November 2015 [.pdf]

Chief Investigator

Mr Ayman Ewies, Sandwell & West Birmingham NHS Trust, Birmingham City Hospital, Dudley Road, Birmingham, West Midlands B18 7QH

Tel: 0121 507 4042

Email: Ayman.Ewies@nhs.net

FOAM Trial Office

Trial Coordinator:  
Senior Trial Coordinator: Rachel Blundred
Trial Management Team Leader:  Claire Gaunt
Trial Statistician:    Ikhlaaq Ahmed

Cancer Research UK Clinical Trials Unit (CRCTU)
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Enquiries

Tel: 0121 414 3792 
Fax: 0121 414 8392
Email: FOAM@trials.bham.ac.uk

Trial Entry

Tel: 0121 414 3792 or 0800 371 969   (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting

Fax: 0121 414 8392 or 0121 414 7989

Sponsor

Sandwell and West Birmingham Hospitals NHS Trust and University of Birmingham