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As conducting clinical trials is a high priority at most major institutions, we, the clinical research staff (nurses, study coordinators and research study assistants) play an important and supportive role in clinical trial activities. We provide administrative assistance to investigators, are responsible for submission of regulatory documents to the Institutional Review Committees, handling and sometimes distributing investigational drugs and data collection/entry. However, the most important responsibility we all have, is to ensure that our study participants receive high quality, scrupulously monitored care while protecting their rights and improving their well being.
With all of the above in mind, I hope you will find the resources and tools on this website useful and will help you to enhance your commitment to clinical research, so it can be said “A Trial Well Done”!
Thank you!
Karen Williams, PSG Executive Member (Coordinator representative)
Karen Williams, BA, CCRP
Northwestern University, Dept. of Neurology
710 N. Lake Shore Drive, 11th Fl
Chicago, IL 60611
(312) 503-5645 (office)
(312) 503-0787 (fax)
k-willliams8@northwestern.edu
• Training/on-boarding new research staff
• Monitoring preparation
• Retention/Recruitment
• Collaborating with Ancillary Depts
Cindy Casaceli, MBA
DirectorClinical Trials Coordination Center
Center forHealth + Technology (CHeT)
University of Rochester
(585) 273-4239
• Clinical Trial Operations
• Trial budgets/Per subject fee
• Data Management
• Data sharing/Data mining
• eConsent
• Telehealth
• Mobile technologies
Sarah Wong, PhD, CCRP
Clinical Research Manager, Neurology
UCSF Movement Disorders and Neuromodulation Center
San Francisco VA Medical Center
(415) 353-7885
(415) 353-9060 (Fax)
• Clinical Trials Operations
• Project Management
Melissa A. Kostrzebski
Senior Project Manager
Clinical Trials Coordination Center
Center for Health + Technology (CHeT)
University of Rochester
(585) 273-4239
melissa.kostrzebski@chet.rochester.edu
• Clinical Trial Operations
• Project Management Monitoring
• Telehealth
• Sensor Technologies
• Protocol and Consent Development
• Recruitment and Outreach
• Data entry / query management
Ray James, BS, RN
Boston University School of Medicine
Department of Neurology
Parkinson Disease and Movement Disorder Center
72 East Concord Street, C3
Boston, MA 02118
(617) 638-7745
(617) 638-5354 (Fax)
• Research Nursing activities
• PD Medications
• Motor function assessments
• Retention/Recruitment
• Preparationfor Monitor Visits
• Cross-Disciplinary Coordination
• Managing Study Budgets
• Training New Research Staff
• Visit Preparation and Source Creation
• SOP development
• Monitoring Preparation
April Langhammer, BA, CCRP
University of Kansas Medical Center
3599 Rainbow Blvd.
Kansas City, KS 66160
(913) 588-6989 (office)
alanghammer@kumc.edu
• Source document creation
• Regulatory preparation
Julia Spears, CCRC
The University of Toledo, Dept. of Neurology
Gardner-McMaster Parkinson Research Center
3000 Arlington Avenue, MS 1083
Toledo, OH 43614-2598
(419) 383-6728 (office)
(419) 383-3063 (fax)
(419) 450-9793 (cell)
julia.spears@utoledo.edu
• Budget development and negotiation
• Study start-up / essential documents
• Regulatory management
• Consent form development
• WIRB submissions
• Data entry / query management
• CRO/CRA and Sponsor relations
• Site template development (Regulatory and source)
Alistair Glidden, BA
Center for Health + Technology
University of Rochester
• Digital and decentralized/virtual trials, including participant and investigator support for telemedicine
• Subject recruitment, including social media advertising and video production
• Training and onboarding new staff
• Database design, including general considerations (question/response/report structure) and specific guidance (REDCap)atea
Stay tuned for more resources on how research is conducted. By the end of this year, the Parkinson’s Foundation will launch a free, open access, online course covering topics including information on ethics and informed consent, analyzing and interpreting research and recruiting representative populations into research.Patient Engagement in Research.
Learn more about the Parkinson’s Foundation’s patient engagement in research program here. Our methodology of patient engagement can be found here. Examples of our Research Advocacy program work on bringing in representative populations to research can be found here and here. To join our efforts, contact Karlin Schroeder, Associate Vice President, Community Engagement, kschroeder@parkinson.org or (646) 388-7641.
More videos coming soon!
Telemedicine for Parkinson’s: A Clinician’s Guide
Telemedicine for Parkinson’s: A Live Demonstration
Video 1: A Brief Introduction to Telemedicine
Video 2: An Introduction to Telemedicine
Video 3: A Comprehensive Introduction to Telemedicine
Additional resources can be found on the University of Rochester’s website here.
Start-up Fees
Clinical Care Expenses
Study Team Effort
Indirect Costs
General Guidance for Using the Regulatory Binder:
1. General Research Studies
Examples include but are not limited to: Questionnaire studies, minimal risk drug studies
a. Protocol/Amendments+
b.Consent/HIPAA+
c. IRB/xIRB*+
d. Training+
e. Case Report Forms (CRFs)+
f. Lab+
g. Instructions for Use (IFU) +
h. Recruitment +
I. CV/Medical Licenses +
j. ParticipantMaterials +
k .Delegation Log+
l. Screening/Enrollment Log+
m. CLIA/CAP/ Lab Certificates +
n. Package Insert
o. Miscellaneous
2. FDA-Regulated Drug Studies
(in addition to #1, maintain the following tabs)
Examples include but are not limited to: Clinical trials, IND submission studies
a. Financial Disclosure ^
b. Study Shipment Supplies^
c. Monitor Log & Letters ^
d. 1572^
e. Investigator Brochure^
f. FDA Submissions^
g. Investigational Product Shipment^
h. Investigational Product AccountabilityLog ^
i. SAE/IND Reports (non-UPIRSO)^
j. SAE/IND worksheets^
k. Correspondence^
3. FDA-Regulated Device Studies
(in addition to #1, maintain the following tabs)
Examples include: Investigational device studies, IDE submission studies
a. Financial Disclosure ^
b. Study Shipment Supplies^
c. Monitor Log & Letters ^
d. FDA Submissions^
e. Investigational Product Shipment^
f. Investigational Product AccountabilityLog ^
g. Investigator Agreement^
h. Correspondence ^
4.Sponsored Research Studies
(in addition to #1, possibly #2 and/or #3, maintain the following tabs)
Examples include: Studies with external funding
a. Sponsor Contact
b. Sponsor Newsletters
c. (Sponsor)Correspondence
Comments
* external IRB (both commercial or non-commercial)
^ use to maintain documents required for FDA-regulated research
+ use to maintain documents to meet Good Clinical Practice (GCP)
The 1572 is an investigator’s signed contract with the FDA, agreeing to uphold federal clinical study obligations. No investigator may participate in an investigation until a 1572 is signed. Device studies use an Investigator’s Agreement Form, which is the equivalent to the 1572.
The PI agrees to personally conduct or supervise the described investigation. The PI agrees to maintain adequate and accurate records in accordance with 21 CRF 312.62 and to make those records available for inspection in accordance with 21 CRF 312.68. The PI ensures that all associates, colleagues, and employees assisting in the conduct of the study are informed regarding their obligation to meet all commitments of the study.
Federal Regulations
International Guidance
Local
The Institutional Review Board (IRB) was established in accordance with federal regulations governing the use of human subjects in research.
The IRB reviews and surveys research to ensure the protection of the rights and welfare of all research subjects.
Investigators cannot initiate or change research protocols until they have received IRB approval.
Required: CITI Web Based Training or other similar program
Required: GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA focus) is suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.
Recommended: Clinical Research Coordinator (CRC)
CITI Program’s CRC course provides a foundational training specifically focusing on operational and regulatory elements necessary for the ethical conduct of clinical research, while at the same time it is specifically tailored for the needs of clinical research professionals. It offers learners a foundation that expands beyond but is directly connected to the Human Subjects Research (HSR) and Good Clinical Practice (GCP) ICH training.
Protocol specific training
Expectations for clinical and research specific procedures, such as laboratory assessments, EKG, vitals, etc.
Expectations for standardized and non-standardized study data collection methods or assessments, such as questionnaires
Sponsor specific training for EDC, Specialty assessments, diary training, specific assessment devices (these may take place at Investigator meeting but most often by additional training modules/webinars)
Shipment of Hazardous Materials (IATA)
Blood Borne Pathogens
FDA Forms and Instructions
Electronic Code of Federal Regulations
Feinberg School of Medicine Policy
Template Logs
Northwestern IRB Resources
References/Works Cited
Internal References
Standard Operating Procedures (SOP) Template/Example
Standard Operating Procedures for Clinical Research Courtesy of April Langhammer, Study Coordinator, University of Kansas
All IRB submissions are done electronically using the institutional IRB system or a Central IRB as allowed by the institution (such as WIRB, Quorum)
Investigator’s Meeting: Prior to study recruitment many sponsors hold IM to train, cover AE and SAE reporting, lab procedures, certify investigators and/or staff in assessments and provide a background on the sponsor and protocol. These may be in person meetings or via Webinar or combined with the Site Initiation Visit (SIV).
Site Initiation Visit (SIV): Following the IM and prior to study start-up, sponsors will hold the SIV to train, cover AE and SAE reporting, lab procedures, certify investigators and/or staff in assessments, collect regulatory documents, verify the Delegation of Authority log and answer questions all site personnel may have about the conduct of the study.
The protocol will specify when a subject is considered enrolled in a study.
Questions to Ask when deciding whether to volunteer for research
Required Elements of Informed consent
Drug storage: Investigational drugs will be stored in the appropriately secured location (i.e. refrigerated or frozen compounds). Accurate and complete drug accountability records MUST be maintained.
Investigational drugs, which are dispensed to patients, shall be dispensed only by authorized personnel (under the supervision of the study physician or registered nurse) and in accordance with all state and federal, and institutional regulations as required by law.
Investigational Drug Disposal: Investigational drugs shall be returned or destroyed according to the protocol and drug company policy. If destroyed on site follow your institutional or facility policies for hazardous waste.
Temperature logs: All logs for drug cabinets, refrigerator and freezer must be maintained and available for review by the sponsor or designees. Some sites use and institutional research pharmacy and the logs are maintained there.
Study Drug Blind Envelopes: In a separate binder, appropriate personnel have access to the blind envelopes for all studies. These blind envelopes are maintained until retrieval by study monitor at closeout. Sometimes these blinds are on the I/P container itself rather than a separate folder. They are however, available to designated study personnel in the event of an emergency. Every effort is made to keep the studies blinded and the sponsor is notified before the blind is broken.
It is important to develop site-specific Research SOP’s.
Include record retention policies, location of offsite storage if applicable, drug destruction policies and plan, specific location of temperature logs and archives of these, maintenance of equipment logs (annual recalibration)
Outline site-specific responsibilities for research requirements
Disaster Plan if one is applicable
Access for monitors to patient electronic records may be based on institutional requirements. Some will have certified copies of the patient records printed and dated and provided by the coordinator. Other sites may actually allow sponsor designees “read-only” access to patient records.
Submit requests 2-3 weeks in advance
Monitor full legal name
Date of Birth
Last four digits of Social Security Number
IRB approval letter
Department
Start date for access
EPIC: 1 year (varies by institution)
Powerchart: 90 days
Signed Confidentiality Agreement
