Study Documentation

Current Study Documentation

• protocol v13 July 2011
• Patient Cards v1 080609

 

Current Forms

• BOSS questionnaire v6 08.12.09
• BOSS EndoscopyPathForm v6.0 July 2011
• BOSS Participant details update form version 2 08.12.09
• Helicobacter update form v1 180608 - revised logo
• Hospital Admission Form (v2 July 2011)
• SAE Form (v4) July 2011
• BOSS Study exit form v4 July 2011

Ethics and Amendments

• Submission letter to REC (18.07.08)
• NHS REC Application Form - Version 5-6[1]
• 08 H0715 91 favourable opinion 15 Sep 08

 

Amendment No.1 (Substantial No.1)

• Notice_of_Substantial_Amendment_(non-CTIMPs)[1]
• REC Favourable Opinion for Amendment No.1, dated 16 January 2009

Amendment No.2 (Non-Substantial)

• submission of minor amendment (23.02.09)
• REC non-substantial amendment confirmation Amendment No.2 (16.03.09)
• REC non-substantial amendment confirmation Amendment No.2 Page 2 (16.03.09)

Amendment No.3 (Substantial No.2)

• REC submission of Substantial amendment (27.03.09)
• Notice of Substantial Amendment (non-CTIMPs) 20.03.09
• REC favourable opinion of amendment No 3 (15.04.09)

Amendment No.4 (Non-Substantial)

• REC submission of minor amendment (27.03.09)
• List of Minor Amendments (27.03.09)
• REC favourable opinion of amendment No 4

Amendment No.5 (Substantial No.3)

• REC submission of Substantial amendment (08.06.09)
• Notice of Substantial Amendment (non-CTIMPs) 08.06.09
• REC Favourable Opinion of Amendment 5 (03.07.09)

Amendment No.6 (Non-Substantial)

• REC submission of minor amendment (18.09.09)
• 08 H0715 91 REC Acknowledgement of Minor Amendment Letter No6 (06.10.09)

Amendment No.7 (Substantial No.4)

• AmendmentFormMinimalRec_ReadyForSubmission[1]
• AD 2010 77 08 H0715 91 Amendment 7 Favourable Opinion letter_Reissued on 20 5 10

Amendment No.8 (Substantial No.5)

• REC submission of Substantial amendment
• AmendmentFormMinimalRec_ReadyForSubmission[1]
• REC Favourable Opinion of Amendment No.8 (27.06.2011)

Amendment No.9 (Substantial No.6)

• REC submission of Substantial amendment 28.07.2011
• 08 H0715 91 REVISED Amendment 9 approval letter 30.09.11
• 08 H0715 91 REVISED Amendment 9 approval letter 30.09.11

Centre Documentation

Site File Template (v6 April 2010)

Delegation Log v3 30.10.09

SAE log (v1, January 2009) 

Trial Site file note (v1, October 2008)

Telephone Log (v1, October 2008) 

Site contact sheet (april 2009)