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Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
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Data Standardization: Standardizing data collection and documentation across study sites is crucial for ensuring consistency and facilitating data analysis. Develop standardized data collection forms, case report forms (CRFs), and electronic data capture (EDC) systems that capture relevant data elements in a consistent manner.
Data Validation and Quality Control: Implement robust data validation procedures to ensure the accuracy and completeness of collected data. Conduct thorough quality control checks, including data validation checks, range checks, and consistency checks, to identify and resolve data discrepancies or errors.
Data Security and Privacy: Ensure data security and protect participant privacy by implementing appropriate measures such as data encryption, secure data transfer protocols, access controls, and adherence to applicable data protection regulations like GDPR or HIPAA.
Data Monitoring and Cleaning: Regularly monitor data collection processes to identify and address data discrepancies, missing data, or outliers. Implement data cleaning procedures to identify and resolve data errors, inconsistencies, and outliers that may impact the integrity and reliability of the study data.
Data Traceability and Audit Trail: Maintain a comprehensive audit trail that captures all changes and activities related to data entry, data modifications, and data review. This ensures data traceability and facilitates data validation and regulatory inspections.
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A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
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Data Standardization: Standardizing data collection and documentation across study sites is crucial for ensuring consistency and facilitating data analysis. Develop standardized data collection forms, case report forms (CRFs), and electronic data capture (EDC) systems that capture relevant data elements in a consistent manner.
Data Validation and Quality Control: Implement robust data validation procedures to ensure the accuracy and completeness of collected data. Conduct thorough quality control checks, including data validation checks, range checks, and consistency checks, to identify and resolve data discrepancies or errors.
Data Security and Privacy: Ensure data security and protect participant privacy by implementing appropriate measures such as data encryption, secure data transfer protocols, access controls, and adherence to applicable data protection regulations like GDPR or HIPAA.
Data Monitoring and Cleaning: Regularly monitor data collection processes to identify and address data discrepancies, missing data, or outliers. Implement data cleaning procedures to identify and resolve data errors, inconsistencies, and outliers that may impact the integrity and reliability of the study data.
Data Traceability and Audit Trail: Maintain a comprehensive audit trail that captures all changes and activities related to data entry, data modifications, and data review. This ensures data traceability and facilitates data validation and regulatory inspections.
Standard Operating Procedures (SOPs): Develop and adhere to well-defined SOPs for data management activities. SOPs should cover all aspects of data collection, processing, validation, cleaning, and archiving, ensuring consistency and adherence to regulatory requirements.
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1) Summary reports that summarize the data
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Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
Pharmacovigilance is a branch of Pharmacoepidemiology and is restricted to the study of adverse effects of drugs.
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The document discusses the key activities involved in clinical study setup for data management, including designing case report forms (CRFs), developing the study database, programming validation and derivation procedures, and conducting user acceptance testing (UAT). It provides an overview of the study setup process and outlines the objectives, requirements, responsibilities, and deliverables for each setup activity.
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Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
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Pharmacovigilance planning
Pharmacovigilance planning is a systematic approach to ensuring the safety of pharmaceutical products, including drugs and medical devices, once they are approved and available in the market. It involves creating strategies, processes, and systems to monitor, detect, assess, and prevent adverse effects or other drug-related problems throughout the product's lifecycle. The ultimate goal of pharmacovigilance planning is to protect patient safety and public health by minimizing risks associated with the use of medical products.
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The document discusses Jonas, the protagonist from the novel "The Giver" by Lois Lowry. It describes Jonas as initially being very obedient and intelligent in the novel, rarely getting into trouble. It infers Jonas is intelligent because he is careful about his word choice and often corrects his friend's language. The document suggests Jonas has a dynamic portrayal throughout the story due to specific events and minor characters he encounters.
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The document discusses the advantages and disadvantages of inverters. It describes a novel interleaved dual buck full bridge three level inverter (IDBFTI) that retains advantages like reducing output ripple current and total harmonic distortion. It also solves the zero sequence circulation current problem through its circuit structure. The interleaved inverter circuits share two power switches, making the system easier to extend. Test results on a 2 kW prototype verify the working principle. The document also analyzes how circulation currents can occur in interleaved half bridge inverters and how the IDBFTI design addresses this issue.
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New social movements arose in response to social changes in the 1960s-70s that undermined traditional social structures. They focused on issues like feminism, environmentalism, and pacifism rather than traditional class politics. Through grassroots organizing, protests, and networking, these movements helped shift public opinion and influence policy on topics like gender equality, environmental protection, and civil rights. Their impact demonstrates how collective action can challenge power structures and effect social and political change.
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- Glucocorticoids such as cortisol increase appetite and food intake, especially for foods high in fat, sugar, and calories. This is likely an evolutionary adaptation for times of stress and danger.
- Glucocorticoids act on the brain in regions that control appetite and food reward. They increase levels of neuropeptides that stimulate appetite and decrease levels of those that inhibit appetite.
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Dysphagia, or difficulty swallowing, is common in Parkinson's disease, occurring in up to 95-100% of later-stage patients. Motor impairments from dopamine loss in the brain cause rigidity, lack of coordination, and reduced sensation in muscles involved in swallowing. Studies using videofluoroscopic modified barium swallow tests reveal impaired laryngeal and hyoid bone movement, lack of epiglottic protection, and prolonged pharyngeal transit times in Parkinson's patients, leading to pooling of material in the vallecula and possible aspiration. Bedside screenings often fail to detect around 80% of swallowing disorders found on more detailed testing.
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The document summarizes the influential actions of three women during the Holocaust: Miep Gies, Irena Sendler, and Gerda Weissmann Klein. Miep Gies hid Anne Frank and her family in Amsterdam and provided them with food, supplies, and moral support. Irena Sendler rescued over 2,000 Jewish children in the Warsaw Ghetto by smuggling them out in boxes and suitcases and placing them with families. Even after being arrested by the Gestapo, she continued her rescue efforts. Gerda Weissmann was a teenage girl placed in a Nazi labor camp who survived through courage and resilience and later shared her story.
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