Newsletter
Our newsletter is distributed 10 times a year and is designed to provide updates, answers, and communications from the CCTO and from the SRC/DSMC.
Current Issue
Apr 2013
Archived Issues
2013
- JanElectronic Submission of IND and IDE Applications Now Available Through CCTO Regulatory
Getting the Word Out About Clinical Trials - FebRequired Trial Registration Updates on ClinicalTrials.gov
Planning for Our 2nd Annual Clinical Trials Awareness Week
Eighth Annual Oncology Clinical Research Forum March 1, 2013 - MarRequired Trial Registration Updates on ClinicalTrials.gov
DSMC Recognizes Participation from Across the Cancer Institute
2012
- JanNew Resources for Coordinators
Certified Copies of Medical Records for Clinical Research
Clinical Trials Awareness Week in the Cancer Center April 23
Seventh Annual Oncology Clinical Research Forum February 3 - FebSRC Update Regarding New Investigator Initiated Studies
New! OnCore Report to Find Protocol Activation Status
Updating Study Information - MarNew Policy Requiring Study Participant Entry in OnCore within 5 Business Days
New Clinical Research Orientation Starts in April
Chain of Custody of Investigational Products - AprClinical Trials Awareness Week, April 23 – 27, 2012 in the Clinical Cancer Center
Reminder: Importance of Reporting Outside Safety Reports (OSRs) to CCTO - MayNew! SRC Appeal Process
New! Guidance Document: Electronic Regulatory Binders
Update on Move to Freidenrich Center for Translational Research - JunRevised Standard Operating Procedure for Serious Adverse Event Reporting
Clinical Trials Awareness Week a Success!
Update on Move to Freidenrich Center for Translational Research - Jul/AugThe Clinical and Translational Research Unit (CTRU) on the Move (Again!)
Update on Move to Freidenrich Center for Translational Research - SepRegulatory Update
Central Institutional Review Board (CIRB) for Cooperative Group Studies
The Freidenrich Center for Translational Research is New Home for Cancer Clinical Research! - Oct Accrual Reporting for the NCI Clinical Trials Reporting Program
Good Clinical Practice Training at the Stanford Cancer Institute
Flu Clinic at the Friedenrich Building
WEBINAR: Using a Quality Improvement Framework to Increase Cancer Clinical Trial Accrual: Lessons Learned - Nov/Dec
SRC Update
New Clinical Service: Supportive Dermatology-Oncology
2011
- JanSixth Annual Oncology Clinical Research Forum February 4, 2011
Good Clinical Practice Training for Investigators - FebDSMC Recognizes Participation from Across the Cancer Center
New Scientific Review Committee Guidelines
Ensuring Your IRB Approval Letter Contains Information Required by Auditors - MarScientific Review Committee Update
The IRB is coming to the Cancer Center Starting March 18th!
Reminder: Good Clinical Practice Training for Clinical Investigators
Patient Experience Workshops for Clinical Staff
Is This Patient On a Research Study?
Clinical Trials Record Retention - Apr GCP Workshop for Cancer Center Research Staff
Assistance with Investigator-Initiated Study Protocol Development
SRC Pre-review of Investigator-Initiated Studies - MayStanford Cancer Institute Name Change
Insurance Authorization: Department of Managed Health Care (DMHC) Communication on Timely Authorization
Requesting Regulatory Services? Contact CCTO Using Its New Email Address - JunReminder: Good Clinical Practice Training for Clinical Investigators
Single Patient Treatment INDs
Investigator-Initiated Protocol Templates Revised - Jul/AugChanges in Authorization Procedures for Adult Cancer Clinical Trial Participants
Instructions for Documenting Trial Participation via Smartphrase .studyinfo - SepSRC Review for Cooperative Group Studies of Rare Cancers
Data and Safety Monitoring Committee (DSMC) Regulatory Binder Audits - Oct Scientific Review Committee (SRC) Review Requirements and Procedures
New Safety Reporting Guidelines for Stanford Investigators Holding INDs
New FDA Guidance on Risk-Based Approach to Trial Monitoring and the Use of In Vitro Companion Diagnostic Devices
New Changes to ClinicalTrials.gov : Responsible Party - Nov/DecClinical Research Orientation and Training
Seventh Annual Oncology Clinical Research Forum February 3, 2012
2010
- JanFifth Annual Oncology Clinical Research Forum February 5, 2010
New Template for Non-Interventional Studies - FebDelays in Clinical Trial Authorizations
Clinical Trials and the Latino Community Seminar - MarRequired Result Reporting for ClinicalTrials.gov (http://clinicaltrials.gov/)
Epic Navigation and Training for Clinical Research
Spectrum/CCTO GCP Course in April - AprInsurance Authorization Updates
Policy on Translation Services for Clinical Research
IRB Address Change
Learn About Cancer Clinical Studies and Caregiving - MayAccrualNet: An NCI Online Resource to Support Successful Clinical Trial Patient Accrual
Financial Assistance for Patients
Keeping Regulatory Binders Up to Date
New Resources for CTCAE v4 - JunResponse Evaluation Criteria in Solid Tumors RECIST Criteria 1.1
Hospital Workstations Upgrading to IE7
HIPAA Authorization When Using the Short Form Consent - Jul/Aug7th Edition of AJCC Cancer Staging Handbook
Update on Scientific Review Committee Policies - SepCancer Clinical Trials Search Engine
Managing IND Safety Reports
AccrualNet Features Trial Matching and Other Recruitment Resources - OctClinical Research Groups “CRGs”
Reporting Serious Adverse Events
Revised Protocol Document Templates for Investigator Initiated Research
Updated SRC Compassionate Use Policy
Eligibility Flowcharts Now Accessible to the Public - Nov/DecReminder About the Importance of Timely Adverse Event Reporting
New IND Seminar Starting Monday January 10, 2011
Matthew Gubens MD, MS, Wins ECOG Young Investigator Scholarship
Cancer Support for the Nikkei Community
2009
- JanBranimir (Brandy) I. Sikic Named Associate Director of Clinical Research
Epic Update: Cancer Center Release, February 3rd
New Procedures for Food and Drug Administration Audits
Cancer Center Core Grant - Review of Protocol and Accrual Reports - FebPlans for Research Staff to Participate in Monitoring
Clinical Trials Listings on the Web Site Update
Participant Drug Diaries - MarCancer Center Standards In-service for Research Staff
Good Clinical Practice Training for Research Staff
How Does the DSMC Determine the Overall Rating for Monitored Studies? - AprCommunicating Protocol Information and Contacts to Nursing
Regulatory Binder Management
OnCore Hints and Tips - MayUpdate on Cancer Center Clinical Trial Contracts
DSMC Protocol Risk Assessment in OnCore - JunCancer Center Grant Competitive Renewal Update
OnCore Version 9 Available in July
Industry Monitor Feedback Form - Jul/Aug2009 Study and Accrual Data Needed Prior to NCI Site Visit
Standard Operating Procedures Review Confirmation
Updated Regulatory Binder Standard Operating Procedure - SepNCI Site Visit - October 15th - Keep OnCore Up-to-Date
Updated Adverse Event Standard Operating Procedure
OnCore Version 9 Now Available
Make Your Study Available on ClinicalTrials.gov and More! - Oct/NovFlowcharts for Scientific Review
Update on Cooperative Groups - DecJoint Commission Ever Readiness
CTCAE Version 4
2008
- JanEpic Training for Research Staff
Consent Forms for Clinical Trials Patients Treated on F-Ground (FGR)
Oncore Updates
SRC Study Prioritization Flow Charts - FebUpdate on Interactions with the Office of Sponsored Research (OSR)
Expediting the Claims Process for our Patients
Stanford Cancer Center Co-sponsors Breast Cancer Conference
Oncore User’s Meeting to be Held at Stanford in February 2009
New Stanford Organization Provides Forum for Clinical Research Staff - MarClinical Research Laboratory is a Resource Available for Translational Studies
Disease Management Program Study Prioritization Flow Charts Launched
Human Subjects in Research Training Reminder
Authorization for Study Patients Receiving Standard-of-Care Treatment at the GCRC
OnCore Update
CIS-EPIC Updates - AprHow Can I Enroll A Patient Who Does Not Meet All Eligibility Criteria?
Cancer Clinical Trials Office Annual Report
Cancer Care Chaplain Accompanies Patients and Families
Clinical Trial Disparities - MayMessage from Beverly Mitchell, MD, Regarding the Scientific Review Committee
Adverse Event Reporting Update
Investigator-Initiated Phase I Trials at the GCRC - JunClinical Trials and Clinical Research
Are You Ready to Enroll Study Participants?
Keeping Your FDA Form 1572 Up to Date
Cancer Education Resources from the National Cancer Institute - Jul/AugUtilizing the Disease Management Flowcharts
Procedures for Reporting Protocol Deviations for Investigator-Initiated Research - SepCancer Center Core Grant Accrual Report Preparation Plans
Logistical Arrangements for Monitoring Visits by External Sponsors - OctNCI Instructor to Present 4th Annual Oncology Clinical Research Forum in January
New Agreement between NCCC and Stanford IRB
OnCore v8.0 Upgrade and Additional Training Available
Writing Precise Protocol Documents - Nov/DecNew Orientation and Training Policies for Cancer Center Research Personnel
Cancer Center Core Grant - Protocol Accrual Review Plans
Clinical Trials Participants Discuss Their Experiences
New OnCore v8 Shortcut - oncore.stanford.edu
Education in Palliative and End-of-Life Care for Oncology (EPEC™-O)
2007
- JanCentral IRB (CIRB) Launch
New Studies from the Concept Stage On
Have You Received Payments for All Sponsor Approved Clinical Trial Expenses?
New Stanford Investigator Initiated Clinical Trial Protocol Document SOP
Silverado Meeting - Feb2006 Open Therapeutic Cancer Studies
Message from F-Ground and E1 Nursing Staff
Diligence Required When Completing Radiology Orders
Clinical Research Records Storage Using Iron Mountain
Registering Study Participants in OnCore
Regulatory Update - MarScientific Review Committee (SRC) To Invite Principal Investigators to Meetings
Notices of Award for Cancer Studies Requiring Scientific Review
Prescriptions for Study Supplies
Regulatory Update - AprNew Study Quick Reference Form for the Clinic and ITA
Hospital Computer Now Available in Monitoring Room (CC1206)
OnCore Tips - MayScientific Review Committee Announces Time to Approval Data
Cancer Clinical Trials Office (CCTO) Survey Results
Tracking Adverse Events - JunRoom for Consenting Study Subjects
Protocol Deviation Reporting: A Common Issue in DSMC Monitoring and a Recommended Improvement Mechanism - Jul/AugNew Eligibility Checklist Requirements for all Investigator-Initiated Trials
Two New SOPs for Multi-Site Trials
Scientific Review Now Required for Epidemiologic, Companion, Ancillary, and Correlative Studies with a Scientific Hypothesis
Expanded and Enhanced OnCore v7 Available August 2nd - SepStanford Cancer Registry Data Available to Researchers
New Laboratory Normal Ranges Policy
New Clinical Trials Web Listings Coming Soon to the Cancer Center Web Site - OctNew: Change to Serious Adverse Event Reporting
Third Annual Oncology Clinical Research Forum November 30, 2007
Locating Clinic Patients Receiving Treatment at the GCRC
Regulatory Update - Nov/DecProtocol Review and Monitoring System (PRMS) Update
NCI Grant Renewal Due; OnCore Must be Up-to-Date by January
OnCore Updates
Premier Center for Cancer Registry and Surveillance Data; the NCCC
2006
- JanA Message from George Fisher
"Unsatisfactory, What is This?": The Importance of Regulatory Binders
Biostatistics Consulting and Collaboration Now Available - FebThe CCTO 2005 Annual Report
Data Safety Monitoring Committee
Informed Consent - MarSafety Reporting Procedures and Forms Changed
Translation of Informed Consent Forms - AprUpdate on NCI Grant Application and Site Visit Plans
- MayNCI Site Visit May 23rd - Study Materials May be Requested that Morning
New Regulatory Binder Standard Operating Procedure (SOP)
Biostatistics Assistance
Posting Trials on the Stanford and clinicaltrials.gov Web Sites - JunInteresting Tidbits
Informed Consent and Assent Forms in Oncore
PRMS Marks One Year Anniversary - Jul/AugNew Cancer Center and IRB Procedures for Safety Reporting
OnCore as a Resource - SepBiostatistics Core Update from Philip Lavori, PhD
New Procedures for IRB Safety Report Submission Now in Effect
New FDA Form 1572 Standard Operating Procedure (SOP) - Oct$25 Million Gift to Support Bench-to-Bedside Research at Stanford in Cancer and Other Diseases- article excerpt
Second Annual Oncology Clinical Research Forum November 10, 2006 - Nov/DecRegulatory Updates
Submission of Protocols to the Scientific Review Committee
Trial Administration