Drug accountability is important to ensure proper control, storage, dispensing and handling of investigational drugs according to regulatory standards. Accurate documentation demonstrates that drugs were administered per protocol and supports validity of study data and conclusions. Key aspects to document include drug receipt, dispensing to subjects, returns, inventory and final disposition. Maintaining proper accountability through documentation protects subjects, validates study conduct and ensures regulatory compliance.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
Drug accountability: an important aspect of clinical researchTrialJoin
Drug accountability is an interesting topic related to clinical research, both for the CRAs and for the clinical research sites. Even though drug accountability isn’t a task that should be performed by the CRA, he or she is still responsible for monitoring and making sure that the site is correctly performing every task related to this field.
The topic of drug accountability is especially important in regards to quality data as well as for patient safety. For this reason, we’ll give you an in-depth explanation of everything that drug accountability entails.
Essential Documents For the Conduct of Clinical TrialClinosolIndia
The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
Drug accountability: an important aspect of clinical researchTrialJoin
Drug accountability is an interesting topic related to clinical research, both for the CRAs and for the clinical research sites. Even though drug accountability isn’t a task that should be performed by the CRA, he or she is still responsible for monitoring and making sure that the site is correctly performing every task related to this field.
The topic of drug accountability is especially important in regards to quality data as well as for patient safety. For this reason, we’ll give you an in-depth explanation of everything that drug accountability entails.
Essential Documents For the Conduct of Clinical TrialClinosolIndia
The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
A Clinical Research Associate (CRA) is a professional who plays a crucial role in the management and monitoring of clinical trials. CRAs are typically employed by pharmaceutical companies, contract research organizations (CROs), or academic research institutions. Their primary responsibility is to ensure that clinical trials are conducted in compliance with the study protocol, applicable regulations, and Good Clinical Practice (GCP) guidelines
A Trial Master File (TMF) is a comprehensive collection of essential documents and records that are generated or collected during the conduct of a clinical trial. The TMF serves as the centralized repository of all study-related documentation and provides a complete and accurate account of the trial's planning, execution, and outcomes. It is an important component of Good Clinical Practice (GCP) and regulatory compliance.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
Clinical data management (CDM) is a covered part in the clinical trial and most commonly used tools for the purpose of effectivity of clinical research
Automating Inventory Management. Manage your inventory efficiently!Soft4
Inventory management can be challenging task, but with the right tools it can be very efficient and let to avoid overstock or understock. Manage your inventory efficiently!
A Clinical Research Associate (CRA) is a professional who plays a crucial role in the management and monitoring of clinical trials. CRAs are typically employed by pharmaceutical companies, contract research organizations (CROs), or academic research institutions. Their primary responsibility is to ensure that clinical trials are conducted in compliance with the study protocol, applicable regulations, and Good Clinical Practice (GCP) guidelines
A Trial Master File (TMF) is a comprehensive collection of essential documents and records that are generated or collected during the conduct of a clinical trial. The TMF serves as the centralized repository of all study-related documentation and provides a complete and accurate account of the trial's planning, execution, and outcomes. It is an important component of Good Clinical Practice (GCP) and regulatory compliance.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
Clinical data management (CDM) is a covered part in the clinical trial and most commonly used tools for the purpose of effectivity of clinical research
Automating Inventory Management. Manage your inventory efficiently!Soft4
Inventory management can be challenging task, but with the right tools it can be very efficient and let to avoid overstock or understock. Manage your inventory efficiently!
YIELD Marketing Control Center MCC is an intelligent web-based solution for consumer marketers to easily create, manage and track all of your mobile, online and social marketing campaigns on a single platform…giving you a 360 degree view of your customers thus deepening your one-to-one customer relationships
That presentation is about the stability of the drug, why it's necessary?? What is the shelf life of a drug? Purpose of stability testing and its importance.Also a review article of Sanjay Bajaj et al published in Journal of applied pharmaceutical sciences.
How do i calculate in movement of goods from one place to another (Domestic l...Independent
Its concerned with operations and movement of small consignments, which is the major issue faced by majority of employees across... This short slide can give an outline on the subject matter.
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Cold Storage Warehouse Best Practices: Warehouse Layout OptimizationAngela Carver
Cold storage warehouse facilities, just like other warehouses and distribution centers, struggle to make the most of their labor resources. One way warehouse operators in the refrigerated environment are addressing these concerns are by focusing on warehouse layout optimization. When facilities are laid out inefficiently or improperly marked many labor hours can be wasted on travel time. Taking the time to address warehouse layout design can help your warehousing operation to achieve maximum space utilization and process improvement. The first stage of warehouse layout optimization is the designation of functional zones. This is done using analytics on past activity and estimates on future needs. These reports will help your team to identify the proper size and location of each zone. This information should be accessible from your warehouse management system where inventory and activity data is recorded. The top 4 functional warehouse zones identified using forecasting and projections are storage, yard/dock, picking and VAS/kitting zones. To identify the proper size of the storage area evaluate key factors such as project inventory levels, temperature requirements, product dimensions, fulfillment rules, flow through rates and more. All of these factors will play a part in determining proper storage layout. Data must also be collected to determine yard and dock door requirements. Too little staging space and dock doors can create a significant bottle neck, slowing down warehouse productivity. When determining picking and shipping size and location identifying your picking strategy will help to make these decisions. Consider the space requirements needed for all types and which will work best for your available resources. If your refrigerated warehousing operation provides any variety of value added services such as kitting space and layout must also be considered for this. Determine what areas require their own designated space and which can operate in shared space. Planning this space effectively will promote faster inventory flow through rates. Leaders in the refrigerated and frozen supply chain are constantly evaluating these factors to ensure their space utilization provides growth opportunities. Do not let an inefficient warehouse layout stop your business from growing. Learn more about this cold storage warehouse best practice in this brief SlideShare.
Warehousing is expensive. cost of the land, building, machinery, labor and the items stored in the warehouse –consumes bulk of money
How do the companies reduce this cost
Maximize the operation by
Streamlining the placement and picking of goods
Reducing the time goods are stored in the warehouse
Automating as much as possible to minimize labor costs
Humans are 99% similar to each other; but it is the 1% that is the cause of concern. This relatively small difference actually how a drug will effect our body. Pharmacogenomics is the study of how genes affect a person’s response to drugs. In order to prevent any unwanted reactions it has become necessary to consider one's genome while prescribing medicine. Thus pharmacogenomics is the starting point of personalized medicine.
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Dispensing of Prescription Rx & Ethic of Pharmacist with PatientsDashty Rihany
A prescription is an order form a registered practitioner or another properly licensed practitioner such as a physician, dentist, Doctor veterinarian or dermatologists etc. to a pharmacist to compound Pharmacy and dispense a specific medicine for the patient.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
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Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
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Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
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The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
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2. Contents
2
1. Introduction
2. Role of documentation
3. Benefits of documentation
4. What should be documented
5. What steps should be carried with investigational drug
6. Responsibilities
7. FDA inspection
8. Conclusion
9. References
3. Introduction
3
Drug accountability : It concern with study drug storage,
handling, dispensing , and documentation of administration,
return and/or destruction of the drug.
Purpose: To create uniform study drug dispensing and
accountability standards & establish procedure for the proper
control, storage, dispensing and handling of investigational
drug in accordance with regulatory standards.
4. Role of Documentation
4
Documentation is the to accountability
Accurate drug accountability records demonstrate that the study drug was
dispensed and administered according to the protocol , support study data
validity and conclusion drawn from those data. If the investigator
adequately maintains the study drug accountability documentation, and the
monitor conducts ongoing reviews, then the records should reflect that the
researcher maintained proper control of administration and distribution of
the study drug. The records, when kept according to the recommendations
presented here, should also indicate that the clinical trial is according to
regulatory obligations.
5. Benefits of documentation
5
1. Help verify patient clinical records and detect possible lot variations.
2. Help verify patient case report form and detect any incompliance.
3. Help identify patients who may have received the drug, as well as the quantities
that they may still have in their possession, should recovery of any unused drug
become necessary to minimize health risks.
4. Support the validity of study data and conclusions drawn from those data.
5. The paper trail would show the receipt of the supplies at the site, the dispensing to
each subject, the amount the subject used or did not use, the amount the subject
returned, and the amount the research pharmacist returned to the sponsor or
destroyed on-site . At any stage of the study, the site staff, the monitor, and the
sponsor can know where their drugs are.
6. What should be documented
6
The site should document drug receipt, subject dispensing and , return of used and
unused supplies to the sponsor (or on-site destruction), and should maintain a
current accounting of all supplies in inventory/storage. The balance-on-hand or
dispensing log should contain he protocol no. ,the investigator site , the drug name
and the medication unit-such as tablets , capsule or vial.
A well mentioned balance-on-hand log allows the study monitor to efficiently assess
drug accountability during routine site visit and at the final drug reconciliation
The final step in the drug accountability process is drug return or destruction. This
action should be properly documented, including protocol and drug identifiers,
units, and lot numbers.
7. Cont.
7
Documentation completed on an ongoing basis of the following:
When drug supplies arrive
When a drug is dispensed
When a drug is returned by subject
When a drug is returned to the supplier, or is destroyed
A pill count on the Drug Accountability Record when a subject
returns unused medication
8. What steps should be carried out with
investigational drug
8
1. Receiving investigational drug shipments.
Be sure that the sponsor's instructions about receipt of the study
drug are followed. Upon opening the package:
Check the shipment and confirm that the contents are intact.
Compare the invoice to the lot number, expiration date, quantity and
dosage.
If there are any discrepancies, report the sponsor immediately.
2. Storing study drug.
Securely lock study drug in a temperature-controlled drug
storage place separate from the other medicines. The drug store
should be according to the conditions specified in the protocol or
the shipping invoice. Keep temperature record, in order to verify
that the drug was stored under the proper conditions.
9. Cont.
9
3. Dispensing according to clinical trial protocol.
This document provides detailed information about dosing, including in-
structions for dose modification and discontinuation; how to prepare, ad-
minister and/or dispense study drug; and how to manage and report side
effects.
Drug may be dispensed to patients according to the protocol. The study-
provided drug should only be used for the patient enrolled in the study and the
drug should only be distributed to the assigned patient. Never change the
medication from one patient to another! If the drug requires admixture, only a
specific nurse or clinical pharmacist can be to dispense and prepare that drug.
10. Cont.
10
4. Disposing of or returning drugs.
During the study, follow the sponsor's instructions concerning drug return
and/or disposal. Document all activities, including protocol and drug
identifiers and units and lot numbers. If applicable, returned supplies should be
attributed to specific study participants. In addition, the records should:
Distinguish between unopened (not dispensed) and unused (by study subjects)
supplies.
Explain broken or lost drug supply.
Account for all supplies.
5. Inventory
Ensure patient treatment schedules against drug supply and monitor expiration
dates. If the drug is not available at the investigative site, do not substitute
from the office stock. Request the treatment immediately to the sponsor. If by
any chance office stock is used inadvertently, you have to document deviations
from the protocol Never use study-supplied drug to replace office stock or
vice versa.
11. Responsibilities
11
1.Principle Investigator (PI):
Accountable for receipt, storage, and dispensing of study drug (See
Procedure
Section 1.0: Inpatient Drug Storage)
Ensure that drug is used in accordance with protocol
2. Clinical research coordinator
Maintaining all documentation related to study drug accountability
including all
shipping receipts/invoicing as part of the study file .
Receipt of drug from sponsor for all in-patient studies
Initiate the Master Drug Accountability Log
12. Cont.
12
Dispense of study drug
Monitor temperature for drug supply storage.
Order drug supply for investigator initiated studies.
Instruct subject on proper use and handling of drug.
3. Monitor
The study monitor is the key to ensuring accurate drug accountability.
During routine visits, monitors should assess the site's drug preparation
and dispensing procedures, as well as subject compliance, and ensure
proper drug storage and log maintenance.
The monitor should also verify that the clinical investigator or an
authorized personal is dispensing the supplies.
13. Cont.
13
monitors should confirm that all supplies are accounted for and returned or
destroyed report and investigate any discrepancies, and resolve all items
before site closure.
By periodically reviewing drug accountability documentation throughout
the study, monitors can identify inappropriate practices as they occur and
retrain site staff as needed. Problems detected early are more easily
resolved. Proper review of drug records could uncover poor subject
compliance with drug administration, incorrect supplies at the site, errant
drug preparation, incorrect randomization, and potential un-blinding of
subjects who were dispensed coded labels.
Upon noting problems, monitors should immediately implement corrective
action plans to prevent future occurrences.
14. Cont.
14
4. Auditor
An auditor should carefully assess drug accountability.
He should confirm that the monitor review drug accountability periodically
and that final drug reconciliation was performed.
An investigative site audit tests the drug accountability process and help
gauge the readiness of records for an FDA inspection.
15. FDA inspection
15
An FDA is the biggest test of the drug accountability process.
FDA inspector assess two main areas:
1. accountability
2.control of test article
FDA inspectors also look at whether the drug was shipped to
designated, authorized individuals listed on form FDA1572.
16. Common findings during FDA inspection
in drug accountability
16
1. Incomplete or inaccurate dispensing records.
2. Failure to maintain adequate drug inventory, such records do
not identify the recipient of the particular lot of drug.
3. Discrepancies b/w drug administration forms and
accountability records.
4. Unavailability of drug distribution records.
These are the various common findings relating to drug
accountability
17. Conclusion
17
Managing drug accountability demands attention to detail but
can be achieved with a trained research team dedicated to
following GCPs, standardized procedures and the study
protocol. Accurate drug accountability enhances patient safety
throughout the clinical trial.