The Study Coordinator’s
Role in Investigatororiginated Studies
Diane Davies RN
Manager, Clinical Research Unit
Helen Diller Family Comprehensive Cancer
Center
Consultant: CTSI and QIU
Let’s talk about you, the study
coordinator ……
•Educated, motivated and you like and care
about people!!!!
•As a study coordinator you often become
attached to the patients and want what is best for
the patients and their families!!!!
Skills you bring to the position:
•Verbal Communication
•Written Communication
•Information Technology Skills
•Problem Solving
•Organizational Skills
•Teamwork with Peers
Skills you will acquire as a Study Coordinator:
•Ethical Conduct-Maintaining Data Integrity, GCP Guidelines
•Drug/Device/Biologics Development
•Clinical Care in a Medical Center Setting
•Clinical Trial Budgets & Financial Management
•Medical and Scientific Terminology
•Regulations and Guidelines applicable to Clinical Research
•Data Management
•Leadership
•Teamwork among Medical Professionals
Objectives
Define an investigator-originated study
Define your role in the 3 stages of a study
I.
Pre-study (study set up period)
II. Study Conduct Period
III. Data Analysis and Closeout
An investigator-originated study is defined as…
•A study that is the PI’s original or collaborative
idea.
•The PI owns the data
•These studies are often sponsored by the NIH
or other agencies that grant money for scientific
ideas.
Other Funding
•At UCSF investigators can also use gift or
departmental funds to finance a study
•Drug manufacturers can also finance this
type of study.
–These studies are usually called
Investigator Sponsored Trials or IST’s
–The manufacturer will supply the
drug/device and may pay per patient enrolled
Investigator-originated studies
include:
•Therapeutic (intended to cure or prolong
a life)
•Symptom management
•Prevention
•Early detection/diagnostic
•Correlative – Imaging/ tissue/ blood
•Population-based studies:
•Epidemiology/Surveys/Observational
•Quality-of-life
The Principal Investigator
is responsible for:
•The entire conduct of the study
•Protocol design
•Funding and approvals from contracts and
grants
•Human subject approvals
•Data collection and analysis
•Publication of results
The investigator must assure the
welfare of all subjects enrolled:
•Subject management:
recruitment practices, HIPAA policies
informed consent process
•Adverse event identification and reporting:
Any serious adverse event must be reported to
the UCSF CHR and if your investigator holds an
IND or IDE that event must be reported to the
FDA through MedWatch reporting program
The Investigator and the Study
Coordinator
SC are hired to “coordinate” the study, you are
not “responsible” for the study….. this can be a
fine line between you and the PI
Developing a rapport with your PI:
– Use the Delegation of Responsibilities Log to start
your conversation with the PI
– The Log is found on the QUI website
– Ask your PI about their vision of the study
• Will this lead to further studies
• Will this device or drug provide new information
• Do they have plans for an abstract or publication/ timeline
The important role of the SC
• Human Subject Protection
– Ensuring that the study and consent have
current CHR approval
– The most current consent is used, the
consent process has occurred and all patients
questions have been answered.
– Subject safety, the protocol is followed and all
serious adverse events are identified and
reported
Examples of SC responsibilities
• CHR applications, renewals and reporting of
SAE / protocol violation
• Scheduling subject visits/ collection of biological
samples
• Interviewing subjects / Collection of
questionnaires
• Abstracting study data into database or Case
Report Forms
• Data Integrity
• Liaison with Medical Center
• Study Budgets
you should know about…….
Regulations for Human Subjects
Office of Health and Human Services &
Office for Human Research Protections (OHRP)
http://www.hhs.gov/ohrp
Food and Drug Administration
http://www.FDA.gov
Code of Federal Regulations
21 CFR parts 11, 50, 54, 56, 312, 314, 812, 814
45 CFR part 46
The organization that is responsible for
providing the infrastructure at UCSF for
clinical research is the Human Research
Protection Program ( HRPP)
Committee on Human Research (CHR)
applications and renewals
Quality Improvement Unit (QIU)
post approval reporting
The CTSI
Clinical & Translational
Research Institute
http://ctsi.ucsf.edu/
Find Consultation Services
Search Research Cores at UCSF
Use Clinical Research Center
CTSI Consulting Services
•
•
•
•
•
•
Biostatistics
Study Design and Implementation
Data Management
Ethics
Health Policy
Bioinformatics Data Analysis
CTSI Consulting Services
• Regulatory Knowledge (RKS) Consultation
– Regulatory requirements (including FDA and
IRB)
– Interactions with regulatory authorities
– Regulatory strategies across the spectrum of
preclinical to late phase clinical research
• http://ctsi.ucsf.edu/research/rks-consult-preview
Drugs/Biologics and Devices
A investigator who files an IND or IDE
application must comply with:
i.
Code of Federal Regulations (CFR)
title 21 – 312 (FDA regulations)
ii. International Conference on
Harmonization (ICH) topic E6,
Guidelines for Good Clinical Practice
(GCP’s)
If you need advice contact CTSI- RKS
Clinical Research Centers
Inpatient and Out-patient locations
•
•
•
•
•
•
•
•
San Francisco General Hospital
Moffitt Hospital
Mount Zion Hospital
Moffitt Pediatrics Hospital
Tenderloin Center
CHORI Children's Hospital
Adults Kaiser Oakland Research Unit
Veterans Affairs Medical Center
CTSI- Clinical Research Centers
Services
•
•
•
•
•
•
Nursing Services
Bionutrition Services
Body Composition & Exercise
Laboratories Sample Processing
Newborn Intensive Care
Neurodevelopmental Evaluation
Prestudy
•What is the objective of the study?
•Who is the target population?
•What are the risks to the subject?
•How and where is the research conducted?
•What are your resources?
Prestudy
•CHR application
•IND/IDE application
•See your MSO regarding:
•study budget
•your role with Grants and Contracts
•space and work supplies
See the Clinic Manager and Administrative Nurse for
both outpatient and inpatients care areas orientation
Recruitment plan
The grant application will define the study
population and target accrual
Tips:
Where is the study population located,
recruitment methods, in person/by letter /by
phone or advertisement
Take a look at the study events and
determine the enrollment plan
Make sure your study is registered at
Clinical trials.gov after you receive
CHR approval
Pre-study data collection
preparation
The data collection needs to support the study objectives
How are you going to gather the data?
How are you going to record and store the data?
Work with the statistician and PI on the data collection
methods
What is source documentation ?
• The original recording of data, such as the
B/P on a VS sheet, a RN/MD note, clinic
note, medication record or infusion records
/ surgical dictation
• Any signed notes by care providers
• Test (lab or image reports) downloaded
from STOR
• ER record
• Telephone notes
Pre Study
• Subject visits– Layout an enrollment schedule – the visit schedule
can snowball and resources will not be available
• PI/MD time
• Clinic schedule/OR schedule
• Interviewers availability
Set up a pt. calendar to inform patients of the
visits and location of appointment ( Maps/printed
directions / parking lots
Source documentation you may
need to develop
• Inclusion/ Exclusion checklist
• Drug compliance diaries or symptom
diaries (make sure the subject signs the
diary as you collect it)
• Log to collect adverse events
• Log to collect concomitant meds
• Log documenting the collection of blood or
tissue samples
What is an Adverse Event
• Any change in the subject health, a new
symptom, an accident or new diagnosis after the
subject has received a drug or device or during
a medical procedure
• These are documented on all device or drug
trials while subjects on study
• They are classified by grade 1-5, or mild,
moderate or severe and death. Relationship to
the experimental drug or device must be
included
Questionnaires
• When using a validated questionnaire you
do not need source documentation
– FACT
– QOL
– Depression Scales
Make sure the form has the subject identifier
and date of completion- some forms require a
signature
Case Report Forms (CRF’s)
• CRF’s is the paper or electronic form that
collect the data needed for study analysis
• Paper vs. Electronic data base
– Use unique identifiers (initials and study
number)
– If data is missing indicate by UNK
– Code entries/ do not use text
• PE Normal = 1 abnormal= 2 not done =3
Your Primary Role in Data Collection is to
Maintain Data Integrity
•Complete and accurate accumulation of
information as specified in the study protocol
•Followed by the accurate transfer of this
information (data) to the data collection
method
•It is preferable to use electronic data entry,
set –up in secure relational database versus
paper forms or an Excel file
Regulatory Files
• Set-up and Maintain Regulatory Binder or
File
– IRB required on-study documentation
•
•
•
•
•
•
•
Initial approval and approved consent
Protocol modification
Single Subject exceptions
Informed consent modifications
Annual renewals
Onsite serious adverse events
Official Communication with the CHR
Enrollment and Screening Logs
•Create a log to track all potential subjects
•Screening logs (initials and dates/ keep
copies of the consents)
•Enrollment logs:
•Name, DOB ,contact information
•Date of consent
•Demographics (reporting to granting
agencies)
•Dates of treatment / evaluation or 1st
questionnaire
Are you ready?
Must have full CHR approval including
recruitment materials !!!
Grant and contracts must have full
authorization and final signatures !!!
Is the study is registered on Clinical
Trials.gov ?
Is the Fund/ DPA set up with a ZZ account ?
Do you know how to link study subjects on
IDX ?
Screening and Enrollment
Document clearly:
Consent procedure
•Determining eligibility –
•time
frame of testing is often very important
•use a checklist
•Obtain signatures of the PI/ NP or other supervisor
•Collect supporting documentation
•Review with PI and obtain signoff
•Inform the patient of the next steps, who informs the
subject that they can participate in the study ??
Give study calendar to the subject with projected
dates and set up the next appt.
•Randomization –who will inform the patient if the study is not double
blind
The subject has been enrolled:
What are my next steps?
Ensure protocol interventions are carried out in a
safe and timely manner per protocol guidelines:
i. Procedures
ii. Laboratory/radiology tests
iii. Study drug administration
Study Implementation and
Documentation
• Documentation specific to protocol
– Note should start with protocol number
– Investigator or staff should clearly document informed
consent process and any re-consenting
– Investigator / RN should document dosing and dose
modifications.
– Investigator should document relationship of adverse
events to study participation, management of event,
and when it resolved
Study Implementation
• Data Collection
– Abstract data from a variety of sources to complete
CRF
– Obtain medical reports; forms for off-site offices
– Create and maintain source documents/shadow
charts
– Enter information on the CRF database/paper
Study Implementation
• Maintain study drug supply/devices
– Shipping receipts, dispensing log
• Document communications with “Medical
Science Liaison (MSL)” regarding study conduct
• Maintain worksheets for investigator/division to
track on-study activities, costs, and scheduling
Study conduct
• Scheduling subject visits and exam- this can be
very time consuming
• Keep up with the subject data collection
• Use study chart (shadow file) to have medical
records at your desk
• Do not forget to set aside time for data entry,
double check or have someone audit your data
• Review the data with the PI, find out when a
presentation or abstract is planned
Study Conduct
• Keep your subject log up to date, track all study
visits
• Review the billing charges to your study
• Liason with your dept finance personnel
• Enter the date off study or completion of study
• If long term follow up of subjects is required create a method to track the next contact –(use
an electronic calendar or excel spreadsheet with
calculations
The PI and SC relationship
Keep your PI and other investigator
informed of any changes and updates
– Meetings 1:1
– Weekly e-mail
– Team meeting
Ask your PI how s/he wants to be informed.
What s/he needs to know about immediately, or
at the end of the day or in a weekly meeting.
The study has ended, what now ??
•
•
•
•
All subject follow-up has ended
All data is collected
Has the pharmacy been notified
All data is entered into a data base and the data
base is “lock”
• If you are not going to be contacting a subject or
reviewing medical records the study may be
“retired at CHR”
• Notify the CHR using the study close-out report
Data Analysis
• Discuss your role with the PI
• Organize the study charts and regulatory files
• Make sure the PI has the electronic data and
there is data back-up
• Remind the PI to acknowledge the CTSI on
publication
• You may want to send subjects a thank you for
their participation and results of the study.
Research Protocol Coordination
Pre-Activation
Protocol Design and
Feasibility
Prepare
Regulatory
Documents
Staff Education
Initiation Meetings
Treatment/
Activate Team
Recruitment
Patient/Family
Education
Informed
Consent
Adverse Event
Collection
On-going
Data Collection
Tumor
Response
Assessment
Protocol
Modifications
Off-Study
Follow-up
Eligibility
Report to IRB
Begin Data
Collection
Dose
Modifications
Off-Study
Follow-up
Budget
Study
Close-Out
Report to
Sponsor/IRB
Report Back
To Sponsor
Update
Patient and
Team
Seven Ethical Principles*
1.
2.
3.
4.
5.
6.
7.
Social or scientific value
Scientific validity
Fair subject selection
Favorable risk-benefit ratio
Independent review
Informed consent
Respect for subjects
*“What Makes Clinical Research Ethical,” Emanuel.
More Training
• Collaborative Institutional Training Initiative –
“CITI” required by the CHR for all key personnel
• Clinical Trials Networks Best Practices
• Medical Center Annual Safety Training
• Safe Shipping and Biohazards
• Blood-borne Pathogens
• Vaccinations and TB testing- Occupational
Health – see your HR dept
• Research Billing (FOT-519)
• IDX, STOR, U-CARE
Study tools from the QUI
Below is a collection of tools to assist in the conduct and
management of clinical research:
• Delegation of Authority Documentation Log
• Screening / Enrollment / Withdrawal Log
• Regulatory File Checklist
• Drug or Biologic Dispensing / Accountability log
• Device Dispensing / Accountability Log
– Example: Study Events Tracking Form
– Example: Tracking System for Deadlines and Reporting
Learn more about your job
• Organizations
– ACRP http://www.acrpnet.org
– SOCRA http://www.socra.org
• Contact Beverly Fein at bfein@cc.ucsf.edu for
local chapter info
– Research Practitioner
http://www.researchpractice.com
These sites have information for
subjects about participation in
clinical trials
• http://www.fda.gov
• http://www.cancer.gov/clinical_trials
• http://www.centerwatch.com