Medication error and traveler RNs

 

Service: Capstone Project Writing
Number of pages: 25 pages (6875 words)
Topic of your paper: Medication error and traveler RNs
Subject: – Nursing

this paper is for Post-graduate, Masters level course

Clinical Research Department
New Study Questionnaire
This form is required to facilitate a review by El Camino Hospital (ECH) and the Clinical Research Department (CRD) in determining the feasibility of performing research using ECH resources. For an overview of the clinical research activation workflow, see page 8.

Study Information Overview:
Investigator Name:
Industry/Sponsor Name:
Complete Study Title:
Protocol Name (or Number):
Industry Sponsor Authored Investigator Authored
Will the Study include use of any of the following ECH Resources? (check all that apply)
ECH Facilities (MV or LG) ECH Staffing Systems and/or data stored within ECH Records

If none of the above boxes are marked, contact the Director of Clinical Research before completing this form (ryan_schroeder@elcaminohospital.org). ECH approval may not be required.

Full Description of Study (Clinical Question/ Aims/Design/Safety Data):
Type of Study:
Clinical Trial – A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
Chart Review – A type of research design in which pre-recorded, patient-centered data are used to answer one or more research question
Registry – An organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose.
Observational – A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in a clinical trial).
Tissue Collection – The collection of any human biological specimen or byproduct obtained from an individual that is sufficient in type and quantity to permit an analysis of its physical or biochemical properties. This definition includes solid tissues, cells, cell cultures, molecules derived from tissues (DNA, RNA, proteins, etc.) and body fluids, and associated data and information.
Nursing Quality – Studies performed to support pursuit of academic degrees and/or department/committee project in the area of nursing quality improvement.
Other –
If Device Study: Pilot/Early Feasibility Pivotal Post Market
Investigational Device (If Investigational: Category A Category B)
FDA Approved for Indication
Phase of Study (for Clinical Trials): N/A
Phase I – Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II – The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III – The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV – Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
Funding Source:

Industry Sponsor Gift Grant from:
Other:
Anticipated ECH Start Date:
Total Number of Years (Including Follow-Up):
ECH Study Location (check all that apply – including location of follow-up visits):
Mountain View Hospital, 4B Los Gatos Hospital Palo Alto Medical Foundation
Physician Office Other:
Is this a Multi-Site study: Yes No – ECH is the only participating site
Contact Information:
Industry/Sponsor Contact Information:
Name:
Phone: Email:
Researcher Name Medical Group Affiliation Researcher Email Address Financial Interest or Advisory Role w/Sponsor?
PI: Yes No
Sub-I: Yes No
Sub-I: Yes No
ECH Therapeutic Area Leading Study:
Behavioral Health Orthopedic Institute
Cancer Center Pulmonology Institute
Gastroenterology Stroke
Heart & Vascular Institute Women’s Health
Neuroscience Institute Other:
Nursing ()

ECH Services Requested:
Clinical Research Department Services Ancillary Department Services/Operational Impact (including consenting/exam/treatment space needs)
IRB Preparation/Submission Imaging –
Contracting Interventional Services –
Budgeting Lab Services –
Clinical Research Coordinator (CRC) Nursing –
Other: OR Services –
Pathology –
Pharmacy –
Pulmonology Services –
Other:
Will the study involve the use of new hardware or software?
Yes No
If yes, describe:
Will any new equipment and/or technical training be needed?
Yes No
If yes, describe:
Quality of Research:
Describe the unmet medical need this study addresses:
Potential to meet unmet medical need is significant
Scientific merit is important but not groundbreaking
Scientific merit is minimal
Describe how study will enhance patient care at ECH:

Do you intend to publish study results either individually or as part of a multi-site effort?
Yes No –
Study Recruitment:

Describe the patient population. This is not a study of patients. It is a study of medication errors and nursing staff.
Male Female Females within a Reproductive Age Group
Inpatient Outpatient

What is the enrollment status of this study across all sites?

Enrollment max for all sites: Enrollment slots available:

Full Study Screening (Inclusion/Exclusion) Criteria:

Anticipated Screen Failure Rate:

How many subjects do you anticipate enrolling?

During the past 12 months, number of pre-screenable patients for this study in your/referring practice:

How will potential subjects be identified?

Will subjects be recruited from outside of ECH’s patient population?
Anticipated challenges to enrollment: (i.e. are inclusion/exclusion criteria reasonable to meet enrollment?)

Will support for a recruitment advertising campaign be needed to enroll patients? Yes No

If yes, describe:

Who will play the primary role in pre-screening subjects?

Principal Investigator Other
Sub-Investigator
Risk Assessment:
Does the study present more than minimal risk to human subjects? (minimal risk means that the probability and magnitude of harm anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests)
Yes No
Are frequent and severe Adverse Events (AE) expected?
Yes No Describe AE Risks:
Are there any known research costs for which ECH will not receive reimbursement?
Yes No
If yes, describe:
If costs of device or medical services are not billable to third party payers, will sponsor provide device at no cost and reimburse for unbillable services? N/A
Yes No Additional information:
Will physicians, research coordinators or staff from outside ECH (other than sponsor) need access to ECH medical records? Yes No
Name:
Phone: Email:
Data Collection:
Protected Health Information (PHI) collected or received as part of the study (check all that apply)
Name All Elements of Dates License/Certificate # Biometric Identifiers
All Geographic Identifiers (smaller than a State) Social Security # Vehicle ID # Photo/Comparable Image
Phone # Medical Record # Device Identifiers/Serial #(s) Any Other Unique Identifier
Fax Number Health Plan # Web URLs
Email Address Account #(s) IP Address #(s)
Please attach the following documents:
Current signed CV for yourself and all sub-investigators, including PI/Co-I research history
Human Subjects Research Certifications for both PI and Co-Investigators
Sample Excel data collection tool attached: Date of Error, Time of Error, Medication Category, Travel RN (Y/N)

— SIGNATURE & DECLARATION PAGE TO FOLLOW —
Signature & Declaration Page
Investigator Responsibilities for Study Conduct
Agree to conduct the study in accordance with all ECH policies, applicable Federal and State laws and in compliance with the current IRB approved protocol(s)

Primary responsibility for the maintenance of research records in accordance with applicable regulations, including documentation of consent forms within patient’s medical record

Agree to personally conduct or supervise the study

Attend the Investigator Meeting and/or send a sub-investigator (as applicable)

Identify subjects for study enrollment in accordance with enrollment strategy and established study specific R&Rs

Timely review of adverse and serious adverse events

Source document review and approval

Meet with monitors during site visits and attend other required meetings as necessary

Timely sign-off of electronic case report forms

Available to clinical research coordinator to discuss and resolve study issues in a timely manor
Principal Investigator Signature: __________________________________________
Date:
Service Line Responsibilities and Study Start-Up Approval
Study aligns with Service Line research strategy

Service Line supports study enrollment projections

Service Line confirms support of study’s financial/risk profile and use of ECH resources based on information within the Clinical Research New Study Questionnaire

Service Line Signature: __________________________________________
Date:

Completed forms should be signed and forwarded (with all attachments) to Ryan Schroeder, Director of Clinical Research at ryan.schroeder@elcaminohospital.org.
ATTACHMENT A
Study Activation Process
All clinical research utilizing El Camino Hospital Resources must be processed through the following workflow, which will be coordinated through the ECH Clinical Research Department. If you have questions, or to get started, contact the Director of Clinical Research at ryan.schroeder@elcaminohospital.org.
Step 1 – Study Interest:
Investigator will communicate initial interest to Clinical Research Department and request a Confidentiality Agreement (CDA) to facilitate delivery of study start-up packet (Protocol, Draft ICF, Draft CTA, Draft Budget, etc.). Note that only ECH authorized signatories may sign CDAs (Investigators are not authorized signatories).
Clinical Research Department will facilitate the review and negotiation of the CDA and delivery of study start-up packet to Investigator for their consideration.
Investigator will perform a comprehensive review all study start-up information.
If Investigator confirms interest, he/she shall complete a New Study Questionnaire. If Investigator is not interested in pursuing the study, he/she will notify the Clinical Research Department to terminate start-up efforts.
Step 2 – Service Line Approval:
Investigator will complete the New Study Questionnaire, sign and submit to Director of Clinical Research who will coordinate review by the appropriate ECH committee (Investigator is required to attend this meeting).
Step 3 – Clinical Research Department’s Feasibility Analysis:
The Clinical Research Department will compile a feasibility analysis to assess a high level financial impact of conducting the study.
Step 4 – Clinical Research Executive Committee:
The Clinical Research Executive Committee (COO, CMO, CFO, CSO, CNO, Chair of Nursing Research Council, Compliance Officer, and Director of Clinical Research) will review all Research proposals monthly for alignment of scientific merit, Hospital research strategy, operational impact, patient safety, and institutional risk. The committee may seek input from Hospital stakeholders as necessary in this assessment.
Investigators or their delegates are required to provide a brief presentation to support consideration of their studies by the committee during the scheduled monthly meetings (coordinated by the Director of Clinical Research).
Approval, denial or a request for additional information will be determined by the Clinical Research Executive Committee. Written notice will be provided to Investigator regarding approval status.
Step 5 – Study Start-Up (parallel processing): Once approved the following activities will begin in parallel
Contracting Budgeting IRB Submission

CTA Drafting/Negotiation
(working with operational stakeholders and escalating issues as appropriate)
Development/Negotiation
(working with operational stakeholders and escalating issues as appropriate)
Clinical Research Department will coordinate and/or prepare and submit IRB application and initiate ICF Development

No research may be conducted using El Camino Hospital Resources until full approval for commencement has been granted by the Director of Clinical Research and the IRB.

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