№ lp_1_2_59291
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This document is a template for tracking concomitant medications in clinical studies, with fields for medication details, dates, and investigator notes.
Note:
Year
Subject:
Concomitant medications tracking
Document Type:
Template
Organization / Institution:
NIMH
Target Audience:
Principal Investigators, study team members
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2019
Institution:
Utah State University
Location:
Logan, Utah
Author:
Linda K. Todd
Degree:
Doctor of Philosophy; Master of Science
Field of Study:
Psychology
Document Type:
Dissertation and Thesis Submission Pages
Approving Authority:
Richard S. Inouye, Ph.D., Vice Provost for Graduate Studies
Academic Level:
Graduate
Subject Focus:
Diagnosis of Anorexia Nervosa, Bulimia Nervosa, and Concomitant Conditions
Related Conditions:
Anorexia nervosa; Bulimia nervosa
Year:
2019
Region / City:
Massachusetts, USA
Subject:
Pharmaceutical policy updates
Document Type:
Update bulletin
Organization:
MassHealth
Effective Dates:
November 8, 2019 – November 25, 2019
Medications Added:
Zolgensma, Abilify Mycite, Adhansia XR, Apadaz, Evekeo ODT, Inbrija, Jornay PM, Katerzia, Krintafel, Minolira, Polivy, Prograf, Qmiiz, Rozlytrek, Sunosi, Triluron, Vyndamax
Changes in Prior Authorization:
Benzodiazepines with opioids, Proton pump inhibitors, Influenza treatments
Brand Name Preferred Updates:
Dexilant added, Voltaren Gel removed
Abbreviations:
PA – Prior Authorization, BP – Brand Preferred, CO – Carve-Out, PD – Preferred Drug
Target Audience:
Healthcare providers prescribing MassHealth-covered medications
Implementation Date:
November 25, 2019
Reference Website:
www.mass.gov/druglist
Updates Type:
Additions, deletions, PA changes, policy clarifications
Clinical Focus:
Concomitant opioid and benzodiazepine usage and safe prescribing requirements
Regulatory Context:
FDA “A”-rated generic equivalents and MassHealth formulary requirements
Healthcare Impact:
Affects MassHealth members outside MCO plans
Year:
2023
Region / city:
International
Topic:
Cardiovascular research
Document type:
Scientific appendix
Organization:
REDWOOD-HCM, SEQUOIA-HCM, FOREST-HCM Investigators
Author:
Ahmad Masri, MD, MS; Martin S. Maron; Theodore P. Abraham, MD; Michael E. Nassif, MD; Roberto Barriales-Villa, MD; Ozlem Bilen, MD; Caroline J. Coats, MD, PhD; Perry Elliott, MBBS, MD; Pablo Garcia-Pavia, MD PhD; Daniele Massera, MD; Iacopo Olivotto, MD; Artur Oreziak, MD, PhD; Anjali Tiku Owens, MD; Sara Saberi, MD, MS; Scott D. Solomon, MD; Albree Tower-Rader, MD; Stephen B. Heitner, MD; Daniel L. Jacoby, MD; Chiara Melloni, MD, MS; Jenny Wei, PhD; MD; Mark V. Sherrid, MD
Target audience:
Cardiologists, researchers in cardiovascular medicine
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Note:
Year
Document Type:
CRF (Case Report Form)
Target Audience:
Research teams, Clinical Study Personnel
Period of Use:
Ongoing during the study
Note:
Year
Topic:
Regulatory compliance, human subject research
Document type:
Checklist
Organization / Institution:
National Institute of Mental Health (NIMH)
Target audience:
Principal Investigators, study team members
Year:
Not specified
Region / City:
Not specified
Topic:
Adverse events tracking in clinical studies
Document Type:
Template
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Site Monitors, Principal Investigators, study team members
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.
Year:
2023
Region / City:
Not specified
Topic:
Clinical trial procedures, data management
Document type:
Manual
Organization / Institution:
National Institute of Mental Health (NIMH)
Author:
Not specified
Target audience:
Principal Investigator, study team members
Effective period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2023
Region / city:
United States
Topic:
Clinical research, FDA IND/IDE, Regulatory compliance
Document type:
Checklist
Organization / institution:
National Institute of Mental Health (NIMH)
Author:
National Institute of Mental Health (NIMH)
Target audience:
Principal Investigators, study team members
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
United States
Topic:
Clinical trials, Regulatory documentation
Document type:
Checklist
Organization / Institution:
NIMH
Author:
NIMH
Target Audience:
Principal Investigators, study team members
Period of validity:
Ongoing
Approval Date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
N/A
Topic:
Delegation of authority, Research study management
Document Type:
Template
Organization / Institution:
National Institute of Mental Health (NIMH)
Author:
N/A
Target Audience:
Principal Investigators, Study team members
Period of validity:
N/A
Approval Date:
N/A
Date of amendments:
N/A
Note:
Year
Subject:
Investigational Product Management
Document Type:
Standard Operating Procedure
Institution:
National Institutes of Health
Target Audience:
Principal Investigator, Study Team Members
Note:
Year
Target Audience:
Principal Investigator and study team members who are delegated to manage investigational products
Year:
2021
Region / City:
Canberra
Topic:
Medication Safety
Document Type:
Policy Statement
Organization / Institution:
Canberra Health Services
Author:
Not specified
Target Audience:
CHS staff, including employees, contractors, volunteers, and students
Effective Period:
Indefinite
Approval Date:
12/05/2021
Amendment Date:
12/05/2021
Year:
2006
Region / City:
Australia
Topic:
Medication management, disability services
Document Type:
Legal / Regulatory
Organization:
Disability Services
Author:
Not specified
Target Audience:
Healthcare providers, professionals in disability services
Effective Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2016
Region / City:
Glendale, CO
Subject:
Medication Bubble Wrap Services for Veterans Affairs
Document Type:
Presolicitation Notice
Agency / Institution:
Department of Veterans Affairs
Author:
Robert Woolfolk
Target Audience:
Contractors, Veteran-Owned Businesses, and Small Businesses
Start Date:
15 Feb 2016
Contract Duration:
1 base year with 4 one-year options and 1 six-month extension
Approval Date:
January 2016
Amendment Date:
Not specified
NAICS Code:
446110
Service Location:
VHASLCHCS Outpatient Pharmacy, Salt Lake City, UT
Description:
Pre-solicitation notice for medication bubble packaging services at Veterans Affairs facilities, detailing contract terms, scope, and bidding process.
Year:
2022-2023
Region / City:
Not specified
Topic:
Medication safety best practices in hospitals
Document Type:
Best practices guide
Organization / Institution:
ISMP
Author:
ISMP
Target Audience:
Healthcare professionals, hospital administrators
Period of Validity:
2022-2023
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2014
Region / City:
United States
Topic:
Medication Administration, Medical Authorization
Document Type:
Authorization Form
Organization / Institution:
245D licensed program
Author:
Not specified
Target Audience:
Individuals receiving medication assistance, legal representatives
Period of Validity:
Ongoing
Approval Date:
January 1, 2014
Date of Changes:
Not specified
Year:
2014
Note:
Program name