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... or collected by external web application)? Yes No. If yes, describe the storage method ... Primary Investigator Signature. ... 5/11/2016 8:06:59 AM ...

How to fill out data inventory-human studies

How to fill out data inventory-human studies:

1. Gather all relevant information: Start by collecting all the necessary details related to the human studies you want to include in the data inventory. This may include study titles, investigators, study dates, study objectives, and any other relevant information.
2. Identify the data sources: Determine where the data for each human study is stored. It could be in databases, electronic health records, physical files, or any other storage system. Make a list of all the sources for each study.
3. Assess data sensitivity: Evaluate the sensitivity of each data source and the type of data it contains. Consider whether the data includes personally identifiable information (PII), sensitive personal information (SPI), or any other sensitive data elements. This step is crucial to ensure appropriate privacy and security measures are in place.
4. Categorize the data: Create categories or labels for the different types of data found in the human studies. For example, you might have categories such as demographics, medical history, lab results, or any specific data elements relevant to your studies.
5. Document data attributes: List the specific attributes or variables within each data category. For instance, under demographics, you might include attributes like age, gender, ethnicity, etc. This step helps to create a more detailed inventory of the data captured within each category.
6. Assess data quality: Evaluate the quality and reliability of the data by considering factors such as completeness, accuracy, and integrity. You may need to consult with the investigators or study coordinators to gather additional information or clarify any uncertainties.
7. Map data flows: Determine how the data flows within and between different systems or entities involved in the human studies. This includes identifying data entry points, data transfers, data storage locations, and data sharing arrangements.
8. Establish data retention and disposal policies: Define the appropriate retention periods for the data collected in the human studies. Ensure compliance with any legal, ethical, or regulatory requirements related to data retention. Additionally, establish procedures for securely disposing of data once it is no longer needed.
9. Implement data protection measures: Take steps to protect the privacy and security of the data within the inventory. This includes implementing access controls, encryption, data anonymization techniques, and any other measures necessary to safeguard the data.

Who needs data inventory-human studies?

1. Researchers: Data inventory-human studies are essential for researchers who want to understand the available data and identify potential datasets for their research projects. It helps them assess the suitability and relevance of the data for their specific needs.
2. Institutional Review Boards (IRBs): IRBs are responsible for reviewing and approving human studies to ensure ethical and regulatory compliance. They require a comprehensive understanding of the data involved in the studies to evaluate the potential risks and benefits for participants.
3. Data custodians: Individuals or organizations responsible for managing and safeguarding the data within human studies benefit from a data inventory. It helps them track and manage the data, ensure compliance with relevant regulations, and respond to data access requests or data breaches effectively.
4. Data protection officers: Data protection officers play a crucial role in ensuring compliance with privacy laws and regulations. They rely on the data inventory to assess data protection measures, identify potential risks, and implement appropriate controls to mitigate those risks.
5. Regulatory authorities: Government agencies or regulatory bodies that oversee human studies rely on data inventories to monitor compliance, conduct audits, and ensure the protection of participant data. It helps them assess the overall data management practices and the adherence to relevant regulations.

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What is data inventory-human studies?

Data inventory-human studies is a list of all the data collected and stored during human studies.

Who is required to file data inventory-human studies?

Researchers conducting human studies are required to file data inventory-human studies.

How to fill out data inventory-human studies?

Data inventory-human studies can be filled out by listing all the data collected, the source of the data, and how the data is stored and secured.

What is the purpose of data inventory-human studies?

The purpose of data inventory-human studies is to track and organize the data collected during human studies for future reference and compliance.

What information must be reported on data inventory-human studies?

Information such as data types, data sources, data storage methods, and data security measures must be reported on data inventory-human studies.