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Displaying records 1 - 17 of 17
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  1. COVID-19 Real-time Symptom Epidemiology Tracker (CORSET): Protocol
    Source: Mongan Institute [Massachusetts General Hospital]
    Date Published: 2/8/2021
    Format: Text
    Annotation: The proposed study will contact health care professionals working at Mass General Brigham (Partners Healthcare) or participants enrolled in the Harvard Nurses' Health Study, Harvard Nurses' Health Study II, Harvard Nurses' Health Study III (NHSII/NHSIII), Growing Up Today Study (GUTS), Health Professionals Follow-up Study (HPFS), American Cancer Society Cancer Prevention Study 3 cohorts and direct them to use "COVID-19 Symptom Tracker," a novel app for mobile devices designed to specifically capture self-reported information regarding symptoms associated with COVID-19 and use of PPE during the current COVID-19 pandemic.

    Language(s): English

    This is the protocol for the COVID Symptom Tracker App: https://dr2.nlm.nih.gov/search/?q=21648
    URL: https://disasterinfo.nlm.nih.gov/content/files/CORSET_DetailedProtocol_v1.9_clean.docx
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Available Formats: Text

    Contact Information: predict@mgh.harvard.edu
    Includes Research Tools: Yes.
    ID: 24213. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  2. Coronagenes: Protocol
    Source: University of Edinburgh
    Date Published: 2/8/2021
    Format: Text
    Annotation: An international population cohort to investigate genetic susceptibility to the novel coronavirus (COVID-19). This study seeks to recruit new participants from the general population during the COVID-19 pandemic into a large genetic epidemiological cohort. Recruitment (and subsequent saliva sampling and antibody testing) will take place remotely. Coronagenes re-purposes much of the infrastructure and expertise from the VIKING II study. This launched in January 2020 and paused in March 2020 due to the pandemic, with over 4,000 participants registered. In Coronagenes, data will be collected at baseline through an online questionnaire and longitudinally for UK participants through linkage to routine NHS data (and where possible other healthcare system data) in electronic health records (EHR).

    Language(s): English    ...[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/2020-04-28%20Protocol%20Coronagenes.doc
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    The is the protocol for the Coronagenes Study: https://dr2.nlm.nih.gov/search/?q=24210

    Available Formats: Text

    Contact Information: Jim Wilson, Professor of Human Genomics, University of Edinburgh Email: jim.wilson@ed.ac.uk
    Includes Research Tools: Yes.
    ID: 24215. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  3. ISARIC Global COVID-19 Follow Up Study Protocol
    Source: International Severe Acute Respiratory and emerging Infection Consortium (ISARIC)
    Date Published: 11/17/2020
    Format: Text
    Annotation: The ISARIC COVID-19 Long term protocol & Case Report Form (CRF) survey is designed to follow up adults and children with COVID-19 over time. It can be used for one off or serial follow up of patients post-hospital discharge and for people who were not hospitalized. It is designed to enable patient self-assessment or clinical led assessment, via post, telephone, online or in-clinic visit for wide dissemination and inclusion using limited resources. It can be combined with sampling and further diagnostics. 

    Includes Common Data Elements From: No
    Population: Patients included in the ISARIC/WHO clinical characterisation study, with a confirmed COVID-19 diagnosis post-discharge at serial intervals
    Language(s): English    ...[See more] [See less]
    URL: https://isaric.org/research/covid-19-clinical-research-resources/covid-19-long-term-follow-up-study/
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Available Formats: Text

    Contact Information: ncov@isaric.org
    Includes Research Tools: Yes.
    ID: 24242. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  4. Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO) COVID-19 Survey Protocol
    Source: National Institute on Drug Abuse (NIDA)
    Date Published: 6/18/2020
    Format: PDF
    Annotation: This document is the protocol for the "Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO) Survey of COVID-19 Risks/Effects, Substance Use, and HIV/AIDS Survey" (https://dr2.nlm.nih.gov/search/?q=22690). The protocol provides the background, study design, preliminary studies, recruitment and participant sampling, study procedures, data collection and measurements, and analytic strategy....[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/C3PNO_COVID-19_Supplement_Protocol.pdf
    Type: Study Design/Protocol
    Includes Research Tools: Yes.
    ID: 24241. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  5. International Sexual Health And REproductive (I-SHARE) Health Survey during COVID-19: Study Protocol for Online National Surveys and Global Comparative Analyses
    Source: Academic Network for Sexual and Reproductive Health and Rights Policy [Ghent University] (ANSER)
    Date Published: 6/2020
    Format: PDF
    Annotation: COVID-19 may have a profound impact on sexual behaviors, reproductive health, and social life across the world. Shelter-in-place regulations that have extended across the globe may influence condomless sex, exacerbate intimate partner violence, and reduce access to essential reproductive health services. Population-representative research is challenging during shelter-in-place, leaving major gaps in our understanding of sexual and reproductive health during COVID-19. This International Sexual Health And REproductive (I-SHARE) study protocol manuscript describes a common plan for online national surveys and global comparative analyses.

    Methods: The purpose of this cross-sectional study is to better understand sexual and reproductive health in selected countries during COVID-19 and facilitate multi-national comparisons. Participants will be recruited in selected countries through an online survey. The survey link will be disseminated through local, regional, and national networks. In each country, a lead organization will be responsible for organizing ethical review, translation, and survey administration. The consortium network provides support for national studies, coordination, and multi-national comparison. We will use multi-level modeling to determine the relationship between COVID-19 and condomless sex, gender-based violence, access to reproductive health services, HIV testing, and other key items. This study protocol defines primary outcomes, pre-specified subanalyses, and analysis plans.

    The I-SHARE study examines sexual and reproductive health at the national and global level. We will use multi-level modeling to examine country-level variables associated with outcomes of interest. This will provide a foundation for subsequent online multi-country comparison using more robust sampling methodologies.

    Population: Adults Only
    Language(s): English    ...[See more] [See less]
    URL: https://www.nlm.nih.gov/dr2/I-SHAREProtocol19June2020.pdf
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available
    Associated Survey: https://www.nlm.nih.gov/dr2/I-SHARE_Survey.xlsx
    Link to study website: https://ishare.web.unc.edu

    Available Formats: PDF

    Contact Information:
    Kristien Michielsen
    Ghent University
    Academic Network for Sexual and Reproductive Health and Rights Policy (ANSER)
    Email: kristien.michielsen@ugent.be

    Joseph D. Tucker
    University of North Carolina at Chapel Hill
    London School of Hygiene and Tropical Medicine (LSHTM)
    Email: jdtucker@med.unc.edu
    Includes Research Tools: Yes.
    ID: 23309. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  6. COVID-19: Well-Being and HRQoL in Cancer Patients and Survivors: Protocol
    Source: University of Miami (UM)
    Date Published: 4/29/2020
    Format: PDF
    Annotation: Cross-sectional study protocol. Sociodemographics: Age -- 18 years or older. Gender -- Nonspecific. Race/ethnicity -- Nonspecific; however, the participant needs to be fluent in English or Spanish. Geographical region: Miami, Florida, and Houston, Texas. Targeted population: ICD-10 confirmed cancer diagnosis for cancer patients or survivors who had an oncology visit within the University of Miami Miller School of Medicine (UM/MSOM) Sylvester Comprehensive Cancer Center health system in the past five years. Study links patient demographic and clinical data via the health system’s electronic data warehouse and uses the survey "Impact of the Pandemic and HRQoL in Cancer Patients and Survivors (IPHCPS)" to assess impacts of COVID-19.

    Population: Adults only
    Language(s): English    ...[See more] [See less]
    URL: https://www.nlm.nih.gov/dr2/Impact_of_the_Pandemic_HRQoL_in_Cancer_Patients_and_Survivors.pdf
    Authors: Penedo, Frank; Antoni, Michael
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Associated survey: https://www.nlm.nih.gov/dr2/COVID-19_IMPACT_HRQOL_QUESTIONNAIRE_FINAL.pdf (https://dr2.nlm.nih.gov/search/?q=22130)
    Includes Research Tools: Yes.
    ID: 22131. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  7. Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers Protocol
    Source: National Institute of Mental Health [National Institutes of Health] (NIMH)
    Date Published: 4/20/2020
    Format: PDF
    Annotation: This protocol provides the rationale, background, objectives, design, methodology, statistical considerations, organization for the National Institute of Mental Health Psychosocial Impact of COVID-19 Survey: https://dr2.nlm.nih.gov/search/?q=22587
    Abbreviated title: MINH COVID Study    ...[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/20_M_N085_Research_Protocol.pdf
    Type: Study Design/Protocol
    Access Notes: Contact Information:
    Study team: NIMHResearchVolunteer@nih.gov
    Joyce Chung, MD, National Institute of Mental Health (NIMH) Intramural Research Program, joyce.chung@nih.gov
    Includes Research Tools: Yes.
    ID: 24225. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  8. Impact of COVID-19 on People Living with Rare Disease and their Families: Protocol
    Source: Rare Diseases Clinical Research Network [National Center for Advancing Translational Sciences] (RDCRN)
    Date Published: 4/8/2020
    Format: PDF
    Annotation: This is the protocol for the "Impact of COVID-19 on People Living with Rare Disease and their Families" (https://dr2.nlm.nih.gov/search/?q=22513). The survey is a brief, self-report, online-based questionnaire administered via REDCap (Research Electronic Data Capture system) to:

    1) Estimate the proportion of patients who live with rare diseases who have been diagnosed with COVID-19 infection;
    2) Describe the characteristics of the COVID-19 presentation and the course of the infection (including treatment) among patients with rare diseases;
    3) Determine whether subgroups of patients defined by sociodemographic variables, geographic location, with particular rare conditions or comorbidity have been affected more frequently or have experienced increased severity of the infection;
    4) Learn about potential interaction between specific treatment regimens and COVID-19 infection, and specifically whether certain antibiotic, immunosuppressive, or anti-inflammatory drugs are associated with the frequency of COVID-19 infection and its severity;
    5) Assess the extent to which the COVID-19 pandemic has affected the life of rare disease patients and their families, including their access to medical care and routine medication;
    6) Learn about the main concerns that people who live with rare diseases and their families have with respect to COVID-19, and determine how the RDCRN can respond by providing information and advice through its network of experts, its consortia, and in collaboration with patient advocacy groups; and
    7) Allow follow-up for patients and families who agree to provide contact information, and linkage of information collected in the survey with data maintained by the RDCRN for patients enrolled in RDCRN research studies.

    Population: High Risk/Special/Unique Populations
    Time to Complete: 20 Minutes
    Mode of Administration: Online (e.g., computer-assisted interview)
    Administered by: Self Administered
    Language(s): English    ...[See more] [See less]
    URL: https://www.nlm.nih.gov/dr2/RDCRN_COVID19_Protocol_08Apr2020.pdf
    Type: Study Design/Protocol
    Access Notes: Associated Survey Instrument: https://www.nlm.nih.gov/dr2/RDCRN_COVID-19_Survey_08Apr20204.pdf (https://dr2.nlm.nih.gov/search/?q=22513)

    Free/Publicly Available

    Available Formats: PDF

    Contact Information: Cincinnati Children's Hospital Medical Center, email: rd.covid19@cchmc.org
    Includes Research Tools: Yes.
    ID: 22514. From: Disaster Lit®a database of the U.S. National Library of Medicine.
    REDCap: Yes.
  9. Household Transmission Investigation Protocol for 2019-Novel Coronavirus (COVID-19) Infection
    Source: World Health Organization (WHO)
    Date Published: 2/28/2020
    Format: PDF
    Annotation: This 31-page household transmission investigation is a case-ascertained prospective study of all identified household contacts of a laboratory confirmed 2019-novel coronavirus (2019-nCoV) infection. It is intended to provide rapid and early information on the clinical, epidemiological, and virological characteristics of 2019-nCoV. The protocol has been designed to investigate household transmission of 2019-nCoV in any country in which 2019-nCoV infection has been reported and households are exposed.

    Population: All/Anyone
    Length: 29 items
    Administered by: Specialist/Doctor/Expert
    Language(s): English    ...[See more] [See less]
    URL: https://www.who.int/publications/i/item/household-transmission-investigation-protocol-for-2019-novel-coronavirus-(2019-ncov)-infection
    Type: Study Design/Protocol
    Access Notes: Direct link to document: https://apps.who.int/iris/rest/bitstreams/1272252/retrieve

    Permission/Request required

    Contact Information: EarlyInvestigations-2019-nCoV@who.int, godata@who.int
    Includes Research Tools: Yes.
    ID: 20698. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  10. First Few X (FFX) Cases and Contact Investigation Protocol for 2019-Novel Coronavirus (2019-nCoV) Infection, Version 2
    Source: World Health Organization (WHO)
    Date Published: 2/10/2020
    Format: PDF
    Annotation: This 65-page protocol, updated on February 2, 2020, has been designed to investigate the First Few X (FFX) cases of 2019 novel coronavirus (2019-nCoV) and their close contacts. It is envisioned that the FFX 2019-nCoV investigation will be conducted across several countries or sites with geographical and demographic diversity. Using a standardized protocol such as the protocol provided here, epidemiological exposure data and biological samples can be systematically collected and shared rapidly in a format that can be easily aggregated, tabulated, and analyzed across many different settings globally for timely estimates of 2019-nCoV infection severity and transmissibility, as well as to inform public health responses and policy decisions.

    Population: All/Anyone
    Length: 6 items
    Administered by: Specialist/Doctor/Expert
    Language(s): English    ...[See more] [See less]
    URL: https://www.who.int/docs/default-source/coronaviruse/20200129-generic-ffx-protocol-2019-ncov.pdf?sfvrsn=595eb313_2&download=true
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Contact Information: godata@who.int, https://www.who.int/godata
    Includes Research Tools: Yes.
    ID: 20719. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  11. ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections
    Source: International Severe Acute Respiratory and emerging Infection Consortium (ISARIC)
    Date Published: 2/2020
    Format: Text
    Annotation: This 22-page protocol is designed for any severe or potentially severe acute infection of public health interest, including COVID-19. It is a standardized protocol that enables data and biological samples to be collected rapidly in a globally-harmonized manner. It can be used for the rapid, coordinated clinical investigation of confirmed cases of COVID-19.

    Population: All/Anyone
    Administered by: Specialist/Doctor/Expert
    Language(s): English    ...[See more] [See less]
    URL: https://media.tghn.org/medialibrary/2020/03/ISARIC_CCP_v3.1.docx
    Type: Study Design/Protocol
    Access Notes: Direct link to Protocol: https://media.tghn.org/medialibrary/2020/03/ISARIC_CCP_v3.1.docx
    COVID-19 Case Report Forms (CRFs) https://dr2.nlm.nih.gov/search/?q=20720

    Freely/Publicly Available

    Contact:: ncov@isaric.org

    Citation: Jake W Dunning, Laura Merson, Gernot G U Rohde, Zhancheng Gao, Malcolm G Semple, Dat Tran, et al. Open source clinical science for emerging infections. Lancet Infect Dis. 2014;14(1):P8-9. https://www.sciencedirect.com/science/article/pii/S147330991370327X?via%3Dihub
    Includes Research Tools: Yes.
    ID: 21650. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  12. Protocol for Assessment of Potential Risk Factors for 2019-Novel Coronavirus (2019-nCoV) Infection Among Health Care Workers in a Health Care Setting
    Source: World Health Organization (WHO)
    Date Published: 1/25/2020
    Format: PDF
    Annotation: This 32-page document is a case-ascertained prospective investigation of all identified health care contacts working in a health care facility in which a laboratory confirmed 2019-nCoV infected patient receives care. This study can be done in health care facilities at all three levels of a health system, not just in hospitals. It is intended to provide epidemiological and serologic information that will inform the identification of risk factors 2019-nCoV infection among health care workers.

    Population: First Responders, Emergency Medical Services (EMS) Personnel, Police/Fire Departments, Healthcare workers
    Length: 12 questions and a 21-day diary
    Administered by: Self Administered/Self Report; Trained Lay Examiner/Interviewer
    Special Considerations: Form 1: "Report Form for health care worker" is completed by worker. Form 2: "Report Form for health care worker" is completed by worker and study coordinator. Form 3: "Laboratory results" is completed by study coordinator. Form 4: "Symptom diary" is complted by worker. Form 5: "Health care facility infection prevention and control" is filled out by a health care facility administrator once for every
    health care facility involved in the investigation.
    Language(s): English    ...[See more] [See less]
    URL: https://www.who.int/publications/i/item/protocol-for-assessment-of-potential-risk-factors-for-2019-novel-coronavirus-(2019-ncov)-infection-among-health-care-workers-in-a-health-care-setting
    Type: Study Design/Protocol
    Access Notes: Direct link to document: https://www.who.int/docs/default-source/inaugural-who-partners-forum/20200131-2019-ncov-health-care-worker-protocol-v1.pdf?sfvrsn=a2b876f8_0&download=true

    Permission/Request required
    Contact Information: World Health Organization (WHO); godata@who.int
    Includes Research Tools: Yes.
    ID: 20741. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  13. COVID-19: Documenting Challenges Faced by California Families with Children 0-5 Years Old on WIC Protocol
    Source: University of California, Davis
    Date Published: 12/19/2019
    Format: Text
    Annotation: This is the protocol for https://dr2.nlm.nih.gov/search/?q=23584. The purpose of the project is to: (1) identify barriers that WIC participants in Los Angeles County are experiencing in using WIC food benefits (e.g., access to WIC-eligible foods); (2) identify additional short-term unmet basic needs (e.g., food and housing insecurity, as well as access to unemployment benefits, healthcare, childcare, and social support while required to remain at home) of low-income families during the COVID-19 pandemic....[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/WIC_COVID_IRB_protocol.docx
    Type: Study Design/Protocol
    Includes Research Tools: Yes.
    ID: 24226. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  14. Oregon State University Chemical Exposure Disaster Study Protocol
    Source: Oregon State University
    Date Published: 9/2017
    Format: Text
    Annotation: The Oregon State University Superfund Research Program and the Pacific Northwest Center for Translational Environmental Health are focused on chemical exposures before, during and after disasters. The Centers developed a broad Disaster Protocol, enabling rapid responses to disasters. In the case of Hurricane Harvey, using the pre-positioned protocol, researchers were able to obtain project-specific human subjects ethical approval and initiate data collection within three weeks of Harvey making landfall in Houston. The protocol pairs the passive sampling wristband with a short, self-report, online-based questionnaire administered via Qualtrics. The passive sampler can be stored at room temperature and mailed to participants with simple written instructions. Participants wear the wristband, typically for seven days. During that time, the wristband passively sequesters exposure to semi-volatile and volatile organic compounds. Participants return the wristband via mail with a pre-paid envelope. Currently, the wristband can be analyzed for over 1,530 chemical analytes. Training materials and recruitment materials are available online: https://superfund.oregonstate.edu/disaster-irb
    The associated Questionnaire can be found: https://dr2.nlm.nih.gov/search/?q=24239

    Language(s): English    ...[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/Oregon%20State%20University%20Chemical%20Exposure%20Disaster%20study%20protocol_04062021.doc
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Citation(s):
    Rohlman, D., Bethel, J., Hoffman, P., Tidwell, LG and Anderson, KA. Oregon State University Chemical Exposure Disaster Study Protocol. Superfund Research Program, Pacific Northwest Center for Translational Environmental Health Research, Oregon State University, Corvallis, OR.

    Available Formats: Text

    Contact Information: Diana Rohlman, PhD. Oregon State University. diana.rohlman@oregonstate.edu
    Includes Research Tools: Yes.
    ID: 24238. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  15. University of Iowa Protocols: Disaster Response Research Project
    Source: University of Iowa (UI)
    Date Published: 4/21/2016
    Format: Text
    Annotation: The University of Iowa's IRB protocol's intent is to establish an umbrella IRB approval for rapid response research in the event of disasters, including floods, fires, earthquakes or chemical spills. The IRB application is created in such a way as to be easily modifiable to fit the needs of the specific organization or disaster that it is being used in response to. This protocol has been successfully used in the field in response to the Iowa Flood of 2008, the Iowa City Landfill fire of 2013, and for a train derailment that occurred in 2014.
    The University of Iowa's Protocols propose that when a disaster occurs, health and home survey information, as well as biological samples, will be collected from all consenting individuals in the vicinity of the disaster area. The University of Iowa has developed an IRB application, questionnaires, and consent documents to facilitate this data collection.

    Disaster Response Research Project Questionnaire Part I https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_Health_Questionnaire_Part1(1).docx
    Disaster Response Research Project Questionnaire Part II https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_Health_Questionnaire_Part2.docx
    IRB Protocol: Disaster Response Research https://disasterinfo.nlm.nih.gov/content/files/IRB_Protocol_Disaster_Response_508-compliant(1).pdf
    Informed Consent Document https://disasterinfo.nlm.nih.gov/content/files/Informed_consent_Disaster_Response-2-1(1).docx
    Minor Assent Document https://disasterinfo.nlm.nih.gov/content/files/Child_assent_document_Disaster_Response(1).docx
    Protocol Amendment Checklist https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_Protocol_Amendment_Checklist.docx
    Disaster Response Research Recruitment Phone Script https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_phone_script.docx
    Disaster Response Home Inspection Checklist https://disasterinfo.nlm.nih.gov/content/files/Disaster_Response_Home_Inspection.docx

    Questions Adapted From:
    Questions on questionnaires obtained from ECRHS http://www.ecrhs.org/Quests/ECRHSIImainquestionnaire.pdf
    1-5, 7-9, 11-12, 14-20, 21-38, 41, 43, 45-49, 52, 54, 56-63, 64-65 68, 71-83; Questions modified from ECRHS
    10, 13; Questions from LEIP
    6, 39, 40, 42, 44, 50, 51, 55, 64-67, 69-70; Questions modified from SF-36
    84-97
    Language(s): English    ...[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/IRB_Protocol_Disaster_Response_508-compliant(1).pdf
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Available Formats: Text
    Includes Research Tools: Yes.
    ID: 24219. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  16. UTMB Rapid Acquisition of Pre- and Post-Incident Disaster Data Protocol (UT-RAPIDD)
    Source: University of Texas Medical Branch (UTMB)
    Date Published: 4/8/2016
    Format: Text
    Annotation: Similar to the NIEHS Rapid Acquisition of Pre- and Post-Incident Disaster Data (RAPIDD) protocol, the UTMB RAPIDD (UT-RAPIDD) protocols main goal is to establish a human subject's research protocol for future research response before or following a natural or manmade disaster including floods, earthquakes, or chemical spills. A research registry of community members and/or first responders who live in close proximity to the disaster area will be created based on their exposure to the disaster. The protocol then provides the steps for collecting sociodemographic, health status, occupational exposure and lifestyle information from that cohort before or immediately following exposure to a disaster area. Additionally, the protocol outlines the collection, processing, and storage of biological samples that will be collected before or immediately after exposure to a disaster area. The UT-RAPIDDs primary goal is to have all steps of a research study completed prior to a disaster so that rapid implementation and data collection can occur.

    UT-RAPIDD Informed Consent form https://disasterinfo.nlm.nih.gov/content/files/RAPIDD_Informed_Consent_UTMB_5-23-16(1).docx
    UTMB Initial Study Approval https://disasterinfo.nlm.nih.gov/content/files/Initial%20FB%20Approval.pdf

    Questions Adapted From: Modified from RAPIDD Protocol
    Language(s): English    ...[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/UPDATED_RAPIDD_Protocol_for_UTMB_IRB_6-7-16_508-compliant.docx
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Available Formats: Text

    Contact Information: Sharon Croisant, MS, PhD
    Principal Investigator
    Department of Preventive Medicine and Community Health
    Director, Community-Based Research Facility, UTMB Center in Environmental Toxicology
    spetrone@utmb.edu
    Includes Research Tools: Yes.
    ID: 24220. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  17. Rapid Acquisition of Pre- and Post-Incident Disaster Data (RAPIDD) Study Protocol
    Source: National Institute of Environmental Health Sciences [National Institutes of Health] (NIEHS)
    Date Published: 7/16/2015
    Format: PDF
    Annotation: This 62-page document provides a pre-planned research study protocol to be used for rapidly implementing a new study at the time of a disaster. The protocol provides the information and documents for creating a research registry of disaster response workers who are rostered before or immediately after deployment to a disaster area. The protocol provides the steps for gathering sociodemographic, health status, occupational exposure, and lifestyle information of the cohort before or immediately after deployment to a disaster area. The protocol includes documents needed to conduct the research such as an informed consent form, enrollment information and questionnaires. The goal is to have all documents and steps developed before a disaster for rapid deployment at the time of a disaster. Researchers may also use this protocol as a model for developing additional ready-to-use protocols for other disaster research efforts....[See more] [See less]
    URL: https://www.nlm.nih.gov/dimrc/RAPIDD_Protocol_v8.0_2015-07-16_508_CLEAN.pdf
    Type: Study Design/Protocol
    Access Notes: Documents included in the Study Protocol:
    RAPIDD Core Registry Form: https://www.nlm.nih.gov/dimrc/RAPIDD_Core_Registry_Form_V3_0_20150421_CLEAN-508.pdf

    RAPIDD Core Specimen Collection Questionnaire: https://www.nlm.nih.gov/dimrc/RAPIDD_Core_Specimen_v1_0_20150304.pdf

    RAPIDD Basic Health Registry Form: https://www.nlm.nih.gov/dimrc/RAPIDD_Basic_Registry_v4_0_20150421_CLEAN-508_a.pdf

    RAPIDD Basic Specimen Collection Questionnaire: https://www.nlm.nih.gov/dimrc/RAPIDD_Basic_Specimen_v1_0_20150304.pdf

    RAPIDD Enhanced Health Registry Form: https://www.nlm.nih.gov/dimrc/RAPIDD_Enhanced_Registry_v4_0_20150421_CLEAN-508.pdf

    RAPIDD Enhanced Specimen Collection Questionnaire: https://www.nlm.nih.gov/dimrc/RAPIDD_Enhanced_Specimen_v2_0_20150421.pdf

    RAPIDD Informed Consent Form: https://www.nlm.nih.gov/dimrc/RAPIDD_ICF_v4.0_20150421_508_OPS.pdf

    RAPIDD Answers to Your Questions: https://www.nlm.nih.gov/dimrc/RAPIDD_FAQs_V4.0_20150421_508.pdf

    Appendix B: Protocol Amendment Checklist: https://www.nlm.nih.gov/dimrc/RAPIDD_Appendix_B_508.pdf

    Appendix D: Example of Protocol Implementation During a Disaster Scenario: https://www.nlm.nih.gov/dimrc/RAPIDD_Appendix_D_508-1.pdf
    Includes Research Tools: Yes.
    ID: 12463. From: Disaster Lit®a database of the U.S. National Library of Medicine.
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