Coordinator Corner

Documents within this page are developed by and for research coordinators to address daily operational questions and requirements for clinical research coordinators working within the SCI.

The below documents relate to established forms referred to in the Guidelines for Practice. They are approved for use at Stanford.

Clinical Labs - Study Protocol Form (DOC) - Oct 27, 2010
Clinical Trial Registration Form - Partially Covered Admission (DOC) - Sep 26, 2018
Clinical Trial Registration Form - Fully Covered Admission (DOC) - Sep 26, 2018
Corrective and Preventive Action (CAPA) Form (DOC) - Oct 1, 2018
Cover Sheet for SAE Reporting (PDF) - Aug 2016
CTRU Basic Template with Med Orders (DOC) - Mar 2, 2016
CTRU Lab Order Template (DOC) - Mar 2, 2016
Form FDA 1572 (PDF) - Aug 29, 2019
Histology/EM Laboratory Research Request Form (DOC) - May 24, 2019
Immunization Guide List (DOCX) - May 31, 2017
Investigational Product Return Form (DOC) - Sep 21, 2016
Patient Reimbursement Expense Detail (XLS) - May 23, 2019
Request for Clinical Laboratory Documentation (DOC) - Jun 20, 2014
SHC Request for Interpeter Services (DOC) - Jun 2, 2014
SU13 (PDF) - Jan 2004
SU13 Electronic (DOC) - Jun 2020
Surgical Observation Hints (DOCX) - May 31, 2017
Tumor Measurement Request Form (DOC) - Jul 24, 2014
Uploading Images in Film Library (PDF) -Jun 2010
Visiting Observer Medical Clearance Packet (PDF) - Jun 2, 2017
NCI Ethnicity and Race Classification (PDF) - Dec 12, 2019

In-Service Materials:

Harmonized Nursing Inservice Template (DOC) - Dec 1, 2020

RedCap Forms:

Study Feasibility of Conduct Review Form
Clinical Trials Feasibility for Nursing Services_V2.1 (PDF) - Dec 9, 2020
SAE Reporting Form (PDF) - Apr 2019
SAE CRF for two agents (PDF) - May 2020
SAE CRF for three or four agents (PDF) - May 2020

Study Logs:

Guidelines for Practice were developed by a diverse group of coordinators from all Clinical Research Groups (CRGs) in the Stanford Cancer Institute with input from the CCTO regulatory group. It is the goal of these documents to clarify how clinical work processes should be accomplished at Stanford. The guidelines do not replace SOPs. They are an abbreviated complement to the SOPs. Find SOPs here

These are general guidelines for CRC to follow. Please seek additional help from leads/managers if the instructions are unclear.

Study Initiation

Opening an Investigator-initiated Trial (PDF) - Coming soon
Opening a Sponsor-initiated Trial (PDF) - Aug 9, 2018
Guideline for Multi-site Study (PDF) - Oct 26, 2017
OnCore Access for Sub-site Personnel (PDF) - Jun 28, 2018

Feasibility Form User Guides

REDCap Initial Feasibility Form User Manual (PDF) - Jun 24, 2020
REDCap Feasibility Form - Manager’s User Manual (PDF) - Nov 10, 2020
REDCap Feasibility Form for Protocol Amendments User Manual (PDF) - Nov 10, 2020

Interdepartmental

Cardiac Monitoring

Study ECGs (PDF) - Oct 26, 2017

EPIC

Adding Coordinators to Clinical Team (PDF) - Oct 26 , 2017
EPIC User Guide (PDF) - Oct 4, 2017
EPIC Informatics Update - Cancer Center Highlights (PDF)
Radiology PACS Viewer Quick Start Guide (PDF) - Feb 15, 2019
Transcribing EPIC Orders (PDF) - Nov 10, 2016

Imaging Management

Imaging Management (PDF) - Oct 30, 2017
Obtaining Adult Tumor Measurements from Radiologists (PDF) - Oct 23, 2015
Placing Orders for SU13 Forms (PDF) - Oct 26, 2017

Interpreter Services

Interpreter Services (PDF) - Nov 30, 2017

Investigational Product

Communication with Investigational Pharmacy (PDF) - Oct 26, 2017
Chain of Custody for Investigational Product (PDF) - Oct 26, 2017
Documentation, Retrieval and Return of Investigational Product (PDF) - Nov 30, 2017

Lab Kits

Guidelines for Preparing Study Kits (PDF) - May 29, 2020
In Patient Research Lab Process (PDF) - Oct 23, 2015
Research Lab Kit Preparation and Shipping (PDF) - Oct 27, 2017

Operating Room

Applying for OR Access (PDF) - Nov 30, 2017

Tissue

Ordering an Interventional Radiology (IR) Biopsy (PDF) - Oct 26, 2017
Requesting Tissue from Pathology (PDF) - Nov 30, 2017
Requesting Tissue from Outside Pathology (PDF) - Nov 30, 2017

Treatment Areas

Scheduling a Remote In-Service with Service Centers_V2 (PDF) - Dec 9, 2020
Study and Patient Initialization for the ITA (PDF) - Mar 16, 2018
ITA EPIC Staff Message - Tip Sheet (PDF) - Dec 20, 2020
Using the CTRU (PDF) - Nov 30, 2017
CRM Tip Sheet for scheduling appointments in the CTRU (PDF) - Oct 26, 2017

Trial Management

Electronic Signatures

Use of Electronic Signatures on Clinical Research Documents (PDF) - Jun 26, 2020

Patient Study Enrollment

Conducting Clinical Care at Outside Institutions (PDF) - Nov 30, 2017
Patient Enrollment (PDF) - Nov 30, 2017
Enrolling a Patient Out of Network (PDF) - May 25, 2017
Patient Prescreening and Screening (PDF) - Oct 26, 2017
Consenting a Non-English Speaking Patient (PDF) - Oct 30, 2017
Eligibility Checklist (PDF) - Oct 26, 2017
Re-Consent of Study Patients (PDF) - Oct 27, 2017
Documentation on Day 1 of Patient Enrollment (PDF) - Oct 26, 2017

Monitoring / Audits

Monitoring Visit (PDF) - Oct 26, 2017

Patient Study Discontinuation

Consent Withdrawal (PDF) - Oct 26, 2017
Documentation When a Patient Comes Off Study (PDF) - Oct 26, 2017

Study Closure

Closure to Accrual and Study Closure (PDF) - Nov 30, 2017

Study Staff Changes

Changing Principal Investigator (PDF) - Jun 11, 2020
Transitioning Coordinators (PDF) - Oct 12, 2020

Regulatory Management

Regulatory Binder

Completing FDA Form 1572 (PDF) - Oct 26, 2017
Electronic Regulatory Documentation (PDF) - Nov 30, 2017

eProtocol

What to do at Continuing Review (PDF) - Nov 30, 2017

FDA

Single Patient Investigational New Drug Use (PDF) - Oct 26, 2017

Event Reporting

How to Report SAE in Investigator Initiated Trials (PDF) - Oct 27, 2017
How to Report SAE in Sponsor Trials (PDF) - Mar 12, 2020
Outside Safety Report (OSR) Reporting (PDF) - Mar 12, 2017
Entering Protocol Deviations in OnCore (PDF) - Oct 26, 2017
Writing a Proper Note-To-File (PDF) - Oct 30, 2017

Financial Management

Award Approval Notice & Notice of Award (PDF) - Nov 30, 2017
How to use Clinical Research Invoicing System for Participants (CRISP) (PDF) - Nov 30, 2017

Coverage analysis

https://med.stanford.edu/spectrum/b1_researcher_resources/b1_2_forms_templates.html

Rather than each coordinator developing their own notes addressing common issues, the Notes to File section is an opportunity to share work rather than each of us reinventing our own.

Compliance with FDA 21 CFR 11 Electronic Records and Signatures (PDF) - Oct 3, 2013
CVs, Licensure, and Lab Information (PDF) - Jan 2017
Delegation of Authority Note to File (DOC) - Sep 18, 2013
Documentation of Certified Copies (PDF) - Sep 11, 2012
Electronic Regulatory Binder - Note to File (PDF) - Dec 21, 2015
Epic Part 11 compliance (PDF) - Oct 25, 2018
eProtocol Part 11 Compliance (PDF) - Jun 10, 2009
Outside Safety Reports Note to File (DOC) - Jul 29, 2016
Policy on Electronic Source Documents (DOC) - Feb 16, 2016
Regulatory Memo (DOC) - Jul 21, 2016
Site Affiliation Memo (DOC) - Aug 14, 2017
Stanford Satellite Locations on 1572 (DOCX) - Oct 5, 2016
Training of Personnel listed on the Delegation of Authority Log (DOCX) - Dec 8, 2015

Use of these documents is not mandatory. They are meant to assist coordinators in managing their trials.

AACI CRI Trial Complexity Form (DOC) - Apr 16, 2014
Adverse Event Log (PDF) - Jul 28, 2017
CCTO CTRU Budget Builder Completion Workflow (PDF) - Apr 1, 2020
Complex Procedure Pricing Workflow (PDF) - May 23, 2018
Complex Procedure Pricing Information (DOC) - Apr 16, 2018
Complex Procedure Pricing: Process for Requesting Hospital Billing Information (DOC) - Apr 16, 2018
Clinical Research Abbreviations (DOC) - Apr 11, 2017
Concomitant Medications Log (DOC) - Jul 29, 2011
Confidential Patient Enrollment Log (DOC) - Jul 29, 2011
CRISP Guide
Delegation of Responsibility Log (DOC) - Nov 30, 2017
Delegation of Responsibility Addendum Template (DOC) - Apr 4, 2019
DSMC Regulatory Binder Checklist (DOC) - Sep 12, 2017
Example patient fee tracker for CRISP (XLXS) - Dec 17, 2012
Financial Resources for Patients (DOC) - Feb 3, 2015
Outside Safety Reports Log (XLS) - Aug 4, 2016
IDS Contact Information (PDF) - Sep 15, 2020
Investigational Drug Policy (PDF) - Apr 30, 2014
Investigational Product Custody Smartphrase Template (DOC) - May 10, 2017
Medical History (DOC) - Jul 29, 2011
Medical Waste Management Plan (PDF) - Mar 2013
Note to File Template (DOC) - Aug 1, 2014
Pathology Research Request Letter (DOC) - Jul 29, 2014
Protocol Amendment Checklist (DOC) - Feb 20, 2020
Protocol Deviation Log (DOC) - Sep 21, 2016
Physician Order Record (DOC) - May 15, 2013
Study Account Number Tracker (DOC) - May 7, 2014
Subject Log (DOC) - Jul 29, 2011
Subject Screening and Recruitment Log (DOC) - Jul 29, 2011
Tumor Measurement Request Log Template (XLXS) - Jun 13, 2014

Infusion Treatment Area (ITA)

Example Standardized ITA Treatment Order (PDF) - Aug 3, 2020
ITA Treatment Order Template (DOC) - Sep 9, 2020
Study Initialization ITA (PDF) - Jun 24, 2020

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