Substantial Amendment 03 Back to 'For participating sites' SA03 REC Cover Letter 14th September 2015 [pdf] SA03 REC Acknowledgement Substantial Amendment Letter 18th September 2015 [pdf] SA03 REC Acknowledgement Substantial Amendment Letter 28th September 2015 [pdf] SA03 REC Favourable Opinion Letter dated 07th October 2015 [pdf] SA03 MHRA Cover Letter 15th September 2015 [pdf] SA03 MHRA Acknowledgement of Amendment 21st September 2015 [pdf] SA03 MHRA Acceptance of Amendment Letter 16th October 2015 [pdf] SA03 Summary of Protocol Changes v1.0 dated 11-Sep-2015 [pdf] SA03 Summary of Patient Document Changes v1.0 dated 14-Sep-2015 [pdf] Trial Protocol v3.0, 02 Sep 2015 [pdf] Trial Technical Summary v3.0, 02 Sep 2015 [pdf] Arm A: AZD4547 – Patient Information Sheet & Informed Consent Form v4.0, 01 Sep 2015 [doc] Arm B: AZD2014 – Patient Information Sheet & Informed Consent Form v4.0, 01 Sep 2015 [doc] Arm C: Palbociclib – Patient Information Sheet & Informed Consent Form v4.0, 01 Sep 2015 [doc] Arm D: Crizotinib – Patient Information Sheet & Informed Consent Form v4.0, 01 Sep 2015 [doc] Arm E: Selumetinib & Docetaxel – Patient Information Sheet & Informed Consent Form v4.0, 01 Sep 2015 [doc] Arm F: AZD5363 – Patient Information Sheet & Informed Consent Form v1.0, 01 Sep 2015 [doc] Arm G: AZD9291 – Patient Information Sheet & Informed Consent Form v1.0, 01 Sep 2015 [doc] Arm NA Cohort NA1: MEDI4736 – Patient Information Sheet & Informed Consent Form v4.0, 01 Sep 2015 [doc] Biopsy for Molecular Testing – Patient Information Sheet & Informed Consent Form v4.0, 01 Sep 2015 [doc] Pre-Trial Research Biopsy – Patient Information Sheet & Informed Consent Form v4.0, 01 Sep 2015 [doc] Post-Trial Research Biopsy – Patient Information Sheet & Informed Consent Form v4.0, 01 Sep 2015 [doc] Arm A: AZD4547 – GP Letter v4.0, 01 Sep 2015 [doc] Arm B: AZD2014 – GP Letter v4.0, 01 Sep 2015 [doc] Arm C: Palbociclib – GP Letter v4.0, 01 Sep 2015 [doc] Arm D: Crizotinib – GP Letter v4.0, 01 Sep 2015 [doc] Arm E: Selumetinib & Docetaxel – GP Letter v4.0, 01 Sep 2015 [doc] Arm F: AZD5363 – GP Letter v1.0, 01 Sep 2015 [doc] Arm G: AZD9291 – GP Letter v1.0, 01 Sep 2015 [doc] Arm NA Cohort NA1: MEDI4736 – GP Letter v4.0, 01 Sep 2015 [doc] Arm A: AZD4547 – Patient Diary v2.0, 01 Sep 2015 [doc] Arm B: AZD2014 – Patient Diary v2.0, 01 Sep 2015 [doc] Arm C: Palbociclib – Patient Diary v2.0, 01 Sep 2015 [doc] Arm D: Crizotinib – Patient Diary v2.0, 01 Sep 2015 [doc] Arm E: Selumetinib – Patient Diary v2.0, 01 Sep 2015 [doc] Arm F: AZD5363 – Patient Diary v1.0, 01 Sep 2015 [doc] Arm G: AZD9291 – Patient Diary v1.0, 01 Sep 2015 [doc] Release of Medical Information Form v2.0, 01 Sep 2015 [doc] AZD4547 Investigator’s Brochure v10, 27 Jul 2015 [pdf] AZD2014 Investigator’s Brochure v5, 15 Jun 2015 [pdf] Palbociclib Investigator’s Brochure dated February 2015 [pdf] Crizotinib Summary of Product Characteristics dated 20 Feb 2015 [pdf] Selumetinib Investigator’s Brochure v15, 30 Mar 2015 [pdf] Docetaxel Summary of Product Characteristics dated 29 May 2015 [pdf] AZD5363 Investigator’s Brochure v6, 19 Mar 2015 [pdf] AZD9291 Investigator’s Brochure v5, 15 Apr 2015 [pdf] MEDI4736 Investigator’s Brochure v7, 29 Aug 2014 [pdf] Screening Registration V2.0 13-Oct-2015 [pdf] Cohort Allocation Form v2.0, 13-Oct-2015 [pdf] (for Trial Office use only) Adverse Event Form v3.0, 07-Oct-2015 [pdf] Concomitant Medications Form v2.0, 07-Oct-2015 [pdf] Deviation Form v2.0, 07-Oct-2015 [pdf] ECG Form v3.0, 21-Oct-2015 [pdf] SAE Completion Guidelines v2.0, 23-Oct-2015 [pdf] SAE Fax cover sheet v3.0, 07-Oct-2015 [pdf] Registration Form v3.0, 21-Oct-2015 [pdf] Core Eligibility Checklist v2.0, 21-Oct-2015 [pdf] Eligibility Checklist - Arm A AZD4547 v2.0, 21-Oct-2015 [pdf] Eligibility Checklist – Arm B AZD2014 v2.0, 21-Oct-2015 [pdf] Eligibility Checklist – Arm C Palbociclib v3.0, 21-Oct-2015 [pdf] Eligibility Checklist – Arm D Crizotinib v2.0, 21-Oct-2015 [pdf] Eligibility Checklist – Arm E Sel & Doc v2.0, 21-Oct-2015 [pdf] Eligibility Checklist – Arm F AZD5363 v1.0, 21-Oct-2015 [pdf] Eligibility Checklist – Arm G AZD9291 v1.0, 21-Oct-2015 [pdf] Eligibility Checklist – NA Cohort NA1 MEDI4736 v3.0, 21-Oct-2015 [pdf] Arm A Laboratory Form v1.0, 22-Oct-2015 [pdf] Arm B Laboratory Form v1.0, 22-Oct-2015 [pdf] Arm C Laboratory Form v1.0, 22-Oct-2015 [pdf] Arm D Laboratory Form v1.0, 22-Oct-2015 [pdf] Arm E Laboratory Form v1.0, 22-Oct-2015 [pdf] Arm F Laboratory Form v1.0, 22-Oct-2015 [pdf] Arm G Laboratory Form v1.0, 22-Oct-2015 [pdf] Arm NA Cohort NA1 Laboratory Form v1.0, 22-Oct-2015 [pdf] Physical Exam Form v2.0, 21-Oct-2015 [pdf] Arm A – G Vital Signs Form v1.0, 21-Oct-2015 [pdf] Arm NA Cohort NA1 Vital Signs Form v3.0, 21-Oct-2015 [pdf] ECHO/MUGA Form v2.0, 21-Oct-2015 [pdf] Serious Adverse Event Form v3.0, 23-Oct-2015 [pdf] Treatment Discontinuation Form v2.0, 21-Oct-2015 [pdf] Combined CRFs dated 03-Nov-2015 [pdf] Pharmacy Manual V3.0_16-Nov-2015 [pdf] CRF Completion guide v3.0_10-Nov-2015 [pdf]