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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
Generalizable
Interventional
Observational
Sponsor
Funder
Human Subjects
Industry Sponsored
Investigator Sponsored
Grant-funded Clinical
21 CRF 312.60
An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator’s care; and for the control of drugs under investigation. An investigator shall, in accordance with the provisions of part 50 of this chapter, obtain the informed consent of each human subject to whom the drug is administered, except as provided in 50.23 or 50.24 of this chapter
21 CRF 812.100
An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator’s care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with part 50 of this chapter. Additional responsibilities of investigators are described in subpart G.
Eligible to serve as the PI
Case-by-case Determination
NOT eligible to server as the PI
Compounds are extracted from natural substances or synthesized in the lab and analyzed for therapeutic value
Pre-clinical testing:
Pharmacodynamics: the observed effect resulting from a certain drug concentration
Pharmacokinetics: Describes the drug concentration-time courses in body fluids resulting from administration of a certain drug dose
Toxicology: Tests the toxicological effects of an agent, including carcinogenicity
Animal Studies: Common animal models for studying compound safety and efficacy include mice, rats, pigs, dogs, and monkeys
Objectives
Objectives should be clearly stated as a hypothesis to be tested
Background
Sufficient background information should be included so that the rationale for the study is clear
Patient Eligibility Criteria
Inclusion and Exclusion criteria should be explicitly stated
Pharmaceutical Information
Information should include product description, storage requirements, stability, route of administration, and toxicity information
Controlled Trials
Randomization
Blinding
Clinical Trial Blinding
Human behavior is influenced by what we know or believe. In research there is a particular risk of expectation influencing findings, most obviously when there is some subjectivity in assessment, leading to biased results. Blinding (sometimes called masking) is used to try to eliminate such bias.
Double blind: usually refers to keeping study participants, those involved with their management, and those collecting and analyzing clinical data unaware of the assigned treatment, so that they should not be influenced by that knowledge.
Double-Dummy: two active compounds, blinding is possible using this method. For example, if we want to compare two medicines, one presented as green tablets and one as pink capsules, we could also supply green placebo tablets and pink placebo capsules so that both groups of patients would take one green tablet and one pink capsule.
Single blind trials: (where either only the investigator or only the patient is blind to the allocation) are sometimes unavoidable.•Open (non-blind) trials. In trials of different styles of patient management, surgical procedures, or alternative therapies, full blinding is often impossible.
The FDA considers blinded clinical trials ethical if they meet the following criteria:
IND Submission Contents
When to Submit an IND
The FDA will notify the PI of approval via formal correspondence containing an IND number and a date of approval. All correspondence and original submission materials should be maintained in the regulatory binder.
Includes information and cautions derived from pre-clinical research
Serves as the official labeling for an investigational drug prior to FDA approval; subsequently, the approved package insert becomes the official labeling
If dangerous side effects are found, the drug is taken off the market or a Black Box may be added
Scientific Research has produced substantial social benefits. It has also posed some troubling ethical problems.
Berlin Code of Ethics: World’s first official regulation of human experimentation, barring non-therapeutic interventions without voluntary consent, as well as experiments on minors and others judged vulnerable or incompetent.
The Nuremberg Code: International code of ethics established in response to inhumane Nazi human experimentation during WWII. The Nuremberg Code established four principles:
▫ Informed Consent
▫ Absence of Coercion
▫ Properly formulated scientific experimentation
▫ Beneficence towards experiment participants
Kefauver-Harris Drug Amendments: Passed to ensure drug efficacy and greater drug safety; drug manufacturers are required to prove to the FDA effectiveness of their products before marketing them and tests for safety during pregnancy are required before a drug can receive approval for sale in the U.S. As a result, the FDA is given closer control over investigational drug studies and FDA inspectors were granted access to additional company records.
Declaration of Helsinki: A statement of ethical principles stating that in medical research on human subjects, considerations related to the wellbeing of the human subject should take precedence over the interests of science and society. This document is widely considered the cornerstone of human research ethics.
The Belmont Report: The National Research Act led to the Belmont Report, which outlined 3 basic principles:
▫ Respect for persons
▫ Beneficence
▫ Justice
Respect for persons: Informed Consent
Beneficence: Benefits in research should outweigh the risks
Justice: Equality in selection and opportunity to participate in research
Code of Federal Regulations (CFR):
International Conference on Harmonization: Good Clinical Practice (ICH GCP E6)
Institutional (IRB) versus Central IRB (usually selected by sponsor but can be WIRB, Quorum or others)
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 theHuman Subjects Research (HSR) andGood Clinical Practice (GCP) ICH training.
