Data Requests Forms:

Data Use Form

Data Use and Publication Policy

SEND COMPLETED DATA USE REQUESTS TO: [email protected]

Forms/References:

PCG Emails Combined 2019 – Pending

PCG Emails Combined Updated 12/28/2018

PCG Naming Convention Updated 10/16/2018

Delegation Log-Template

Deviation Report Form

SAE Form

Patient Transfer Form

PCG Conflict of Interest & Confidentiality Form

PI Information & Attestation Form

Subject Identification List

CTCAE Quick Reference

CTCAE v 5.0 – Common Terminology Criteria for Adverse Events

Performance Status Conversion Table

Registry Study:

---

REG001-09 Protocol – Current 

REG001-09 Study Procedure Manual

REG001-09 Treatment Arm Study Assignment v3 excel

REG001-09 Treatment Arm Study Assignment PDF

REG001-09 Adverse Event 

Dr. Tseng NHL_HL CRF Definitions PowerPoint 3/16/16

GU Study Worksheets:

---

EPIC QoL Survey for PCG Studies

GU Adverse Event

GU002-10 Protocol – Current

GU002-10 Study Procedure Manual

GU002-10 Eligibility

GU002-10 Dosimetry

GU003-10 Protocol – Current

GU003-10 Study Procedure Manual

GU003-10 Eligibility

GU003-10 Dosimetry

GU010-18 Protocol – Current

GU010-18 Study Procedure Manual

GU010-18 Eligibility

GU010-18 Dosimetry

GU010-18 Adverse Events Assessment Form

Pancreas Study Worksheets:

---

PAN009-18 Protocol – Current

PAN009-18 Study Procedural Manual

PAN009-18 Eligibility

PAN009-18 Dosimetry

PAN009-18 Adverse Events Assessment Form

PAN009-18 Capecitabine Pill Diary

Other Worksheets:

---

Breast Adverse Event

Lung Adverse Event (without chemotherapy)

Lymphoma Adverse Event

Pancreas Adverse Event

EDC Resources:

EDC Request Form

Training Request Survey

EDC Manual – temporary use 

EDC Guidance 2 Primaries & Metastatic Disease

Alexandria Log In Instructions

eCRF Mislabeling Instructions

Adverse Event Reporting Guidelines 10/12/2018

EDC Videos:

Alexandria Basic Training – Edited (recorded 12/7/2017)

Alexandria Training – Adding a Treatment Arm (recorded 7/6/2018)

Alexandria Training – Baseline eCRF Data Entry (recorded 5/11/2018) 

Alexandria Training – End of Treatment Data Entry Part 1 (recorded 7/6/2018)

Alexandria Training – End of Treatment Data Entry Part 2 (recorded 7/6/2018)

Alexandria Training – Follow Up Data Entry Part 1 (recorded 11/2/2018)

Alexandria Training – Follow Up Data Entry Part 2 (recorded 11/2/2018)

Alexandria Training – Adverse Events Data Entry (recorded 12/26/2018)

Alexandria How to Link a Pt in Multiple Studies (recorded 2/16/18)

Alexandria New Form Display (recorded 3/28/2018)

Alexandria New Table Format (recorded 4/26/2018)

Alexandria File Upload Feature (recorded 5/17/2018)

Alexandria How to Request Support (recorded 9/25/2018)

Breast Study Worksheets:

BRE007-12 Protocol – Amendment 1 (27Oct2017)

BRE007-12 Study Procedure Manual (SPM)-Amendment 1

BRE007-12 Eligibility – Amendment 1

BRE007-12 Adverse Event

BRE007-12 Cosmesis

BRE007-12 Dosimetry

BRE007-12 QoL – Amendment 1 

BRE008-12 Protocol – Current

BRE008-12 Study Procedure Manual

BRE008-12 Eligibility

BRE008-12 Acute Skin Toxicity

BRE008-12 Late Skin Toxicity

BRE008-12 Adverse Event

BRE008-12 Cosmesis

BRE008-12 Dosimetry

BRE008-12 Post Lumpectomy QoL

BRE008-12 Post Mastectomy QoL

Lung Study Worksheets:

LUN005-12 Dose Levels Currently Enrolling (updated 4/12/19): Dose Level 4

Lung Adverse Event

LUN005-12 Protocol – Current

LUN005-12 Study Procedure Manual

LUN005-12 Eligibility

LUN005-12 Subject Registration

LUN005-12 Dosimetry-Dose Level 1 – Amend 6 (CLOSED)

LUN005-12 Dosimetry-Dose Level 2 – Amend 6 (CLOSED)

LUN005-12 Dosimetry-Dose Level 3 – Amend 6 (CLOSED)

LUN005-12 Dosimetry-Dose Level 4 – Amend 6

LUN005-12 Dose Modification

LUN005-12 Response Status Assessment