Describe the Relevant Prior Experience and Gaps in Current Knowledge - Management Assignment Help

Assignment Task:

Task:

INSTRUCTIONS:
Use this RECORDS REVIEW PROTOCOL TEMPLATE to prepare a document with the information from following sections. This version is to be used for “records review” studies only.
Please remove all instructions in red so that they are not contained in the final version of your local protocol.
Study Title
Include the full protocol title as listed on the application form.
Objectives
Describe the study purpose, specific aims, or objectives.
Background

• Describe the relevant prior experience and gaps in current knowledge.
• Inclusion and Exclusion Criteria
• Describe the criteria that define the type of records to be included or excluded in your final study sample.
• Indicate specifically whether you will include or exclude each of the following special populations: (You may not include members of the below populations as subjects in your research unless you indicate this in your inclusion criteria.)
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Procedures Involved
• Describe and explain the study design.
• Describe how the records to be reviewed will be identified.
• Describe the type of data to be collected; attach a copy of the Data Collection Sheet.
• Provide the date range of the records review (if this is a retrospective chart review, the end date must come before the IRB submission date): mm/dd/yyyy to mm/dd/yyyyData Management
• Describe the data analysis plan, including any statistical procedures.
• Risks/Benefits
• Describe the risks/benefits as a result of access to the records.
• Tailor this section to your potential facility where your research could be conducted. Examples given below.
• Setting
• Describe the sites or locations where your research team (specifically indicating from where records will be accessed) will conduct the research; specifically, where records will be reviewed and stored.
• Resources Available
• Describe the qualifications (e.g., training, experience, oversight) of you and your staff as required to perform their role. Provide enough information to convince the IRB that you have qualified staff for the proposed research.
• Local Number of Charts
• Indicate the expected number of records to be reviewed locally.
• Confidentiality
• Describe to extent to which Confidentiality can be expected. Example given below.
• Your description should match your area of practice.
• Here is an example: Medical records will be reviewed in the medical records department and returned immediately to be filed. Data will be collected and stored in a computer using a number to identify each patient in place of their name. A database form will be completed in each patient using a number to identify each patient. The data will be stored on one computer in the principal investigator's office. The address is . The computer will be password protected, and the database itself will be password protected as well. The only member(s) of the study team with access to it will be . The data will be stored for up to 7 years after the study is completed and will be destroyed in accordance with institutioni policies thereafter.
• Consent Process
• If the study involves the retrospective review of charts, there will likely be no prospective contact with potential subjects prior to data access. As a result, the study team will require a Waiver of Informed Consent as well as a Waiver of HIPAA Authorization.
• HIPAA – Protected Health Information (PHI):
• Participant Identifiers
• To which of the following protected health identifiers about participants (or their relatives, household members or employers) might access be needed during the course of the proposed research?
• Check all that apply:
• ___ Names
• ___ Geographic subdivisions smaller than state (e.g. street address, city, five digit zip code, county)
• ___ Months of specific dates (e.g. birth date, admission date, month of discharge, date of death)
• ___ References to age 90 or older or references to dates or years indicative of age 90 or older
• ___ Telephone numbers
• ___ Fax Numbers
• ___ E-mail addresses
• ___ Social security numbers
• ___ Medical record or prescription numbers
• ___ Health plan beneficiary numbers
• ___ Account numbers
• ___ Medical device identifiers or serial numbers
• ___ Biometric identifiers (e.g. finger or voice prints)
• ___ Full face photographic images or comparable images
• ___ Web Universal Resource Locators (URLs)___ Internet Protocol (IP) address numbers
• ___ Certificate or license numbers (e.g. driver’s license numbers)
• ___ Vehicle identifiers or serial numbers (e.g. license plate numbers, VINs)
• ___ Linkage codes (to permit re-identification or longitudinal tracking) derived from or related to any of the above.

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