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.
Monitoring plan and basic monitoring visits: everything that a cra needs to knowTrialJoin
A monitor in a clinical trial is also called a CRA - clinical research associate. This person is a professional who’s responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations, and good clinical practice.
Whether you already are a CRA or you’re trying to become one, the most important thing you should be aware of is the monitoring plan. You, as a CRA or a future CRA, should know what a monitoring plan is, what it serves for, and what it consists of. The second most important information for you are the monitoring visits. Below, we’ll explain all the components of a monitoring plan, as well as which are the most basic and important monitoring visits.
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.
Monitoring plan and basic monitoring visits: everything that a cra needs to knowTrialJoin
A monitor in a clinical trial is also called a CRA - clinical research associate. This person is a professional who’s responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations, and good clinical practice.
Whether you already are a CRA or you’re trying to become one, the most important thing you should be aware of is the monitoring plan. You, as a CRA or a future CRA, should know what a monitoring plan is, what it serves for, and what it consists of. The second most important information for you are the monitoring visits. Below, we’ll explain all the components of a monitoring plan, as well as which are the most basic and important monitoring visits.
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 Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
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.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
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
Helpful information on getting a clinical research job as a craTrialJoin
Clinical research is nowadays considered to be a fast-growing business, so many people are trying to look for ways to enter. There are many work positions in a clinical research facility, all depending on your experience and qualifications.
If you’re reading this, then probably you’re also interested in getting a clinical-research-related job position. And that’s great because this article is exactly for you!
Next, we’ll help you prepare for a job interview in clinical research, no matter which position you’re applying for! People who are interested in this field, are usually trying to get a job as a study coordinator, a CRA, or a research assistant. However, the strategies and tips we’ll give you can be applied to any research-related job!
CTMS for your site's financial activitiesTrialJoin
Accurately tracking and managing financials is important for your site's successful conducting of a trial, as well as the site's general success in the long-run.
There are 2 possible outcomes by not taking proper care of your site's financial activities, either you're losing unaccounted money or you're spending a lot of unnecessary time and effort to make sure you're not missing anything.
Sites nowadays use electronic systems for financial management such as a CTMS (clinical trial management system).
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
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.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
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
Helpful information on getting a clinical research job as a craTrialJoin
Clinical research is nowadays considered to be a fast-growing business, so many people are trying to look for ways to enter. There are many work positions in a clinical research facility, all depending on your experience and qualifications.
If you’re reading this, then probably you’re also interested in getting a clinical-research-related job position. And that’s great because this article is exactly for you!
Next, we’ll help you prepare for a job interview in clinical research, no matter which position you’re applying for! People who are interested in this field, are usually trying to get a job as a study coordinator, a CRA, or a research assistant. However, the strategies and tips we’ll give you can be applied to any research-related job!
CTMS for your site's financial activitiesTrialJoin
Accurately tracking and managing financials is important for your site's successful conducting of a trial, as well as the site's general success in the long-run.
There are 2 possible outcomes by not taking proper care of your site's financial activities, either you're losing unaccounted money or you're spending a lot of unnecessary time and effort to make sure you're not missing anything.
Sites nowadays use electronic systems for financial management such as a CTMS (clinical trial management system).
Most of you who are already involved or familiar with clinical research are probably aware that there are different phases in conducting a clinical study: Phase I, Phase II, Phase III and Phase IV. Another thing you might be familiar with is that Phase I studies can be particularly hard to get, especially for new research sites.
How different are Phase I studies in practice?
To answer this question and many more, we’ve decided to clarify some common misconceptions regarding Phase I trials. We will help you understand what it means to conduct a Phase I trial and how profitable these trials will be for your site.
Regulations in clinical research: obligations and responsibilities of investi...TrialJoin
Two of the most important individuals in a clinical trial are investigators and sponsors. However, being such a crucial part of a trial also brings many obligations and responsibilities. Although the sponsor is the one who initiates and finances a trial, the investigator is the person who conducts it. For this reason, most of the obligations and responsibilities fall on the investigator as the person accountable for everything that goes wrong in a trial. Learning these obligations and knowing how to follow them is a crucial practice that will ensure compliance in a clinical trial.
For this reason, we’ve decided to compose this material that will give you a basic outline of all the rules and regulations that investigators and sponsors should follow.
A newcomer to recovery needs to have the tool box filled. Here is one great tool in preventing relapse. Play the tape through to the end. Read here about putting this into action.
The Culture of Addiction and the Culture of RecoveryDawn Farm
"The Cultures of Addiction and Recovery" was presented by Robin Edison, M.Ed., LPC, NCC, CAAC, Coordinator of the Dawn Farm Huron Street program; and Quintin Williams, BS, CAC-M; Dawn Farm Huron Street therapist. This program discusses the cultural elements of addiction and recovery, explores the role of “cultures” in addiction and recovery, and describes how the symptoms and behaviors of culturally enmeshed alcoholics and addicts change as the individual moves from the culture of addiction to the culture of recovery. This program is part of the Dawn Farm Education Series, a FREE, annual workshop series developed to provide accurate, helpful, hopeful, practical, current information about chemical dependency, recovery, family and related issues. The Education Series is organized by Dawn Farm, a non-profit community of programs providing a continuum of chemical dependency services. For information, please see http://www.dawnfarm.org/programs/education-series.
Have you heard some things about rehab that make you not want to go? Some people think that rehab is boring, or that others will judge them. This is simply not true.
We debunk these and other top myths about rehab in this slideshow.
www.recovery.org
Preparing for a Clinical Research Monitoring Visit: Guidance for an FDA Audit...CTSI at UCSF
Guidance for an FDA Audit, Sponsor/CRO Monitoring Visit, and Other Resources Available on The HUB. Presented by Marlene Berro, MS, RAC, UCSF.
Access the UCSF Clinical Research Resource HUB at http://hub.ucsf.edu/
There are many myths surrounding drug addiction, such as 'all drug users are addicts' or 'only hard drugs are dangerous'. In this slideshow, we bust these myths and provide the truth around drug addiction.
www.drugabuse.com
What Is IP?
IP/ IMP – Investigational Medical Product
An investigational product refers to a preventative (vaccine), a therapeutic (drug or biologic), device, diagnostic, or palliative used in a clinical trial.
What is IP manufacturing?
IP Manufacturing responsibility lies with the sponsor with any applicable GMP.
Any changes in the investigational or comparator product during the course of clinical development – additional studies need to be check for formulated product whether these changes would significantly alter the pharmacokinetic profile of the product.
What is Labeling?
The IP label contains information on :
Composition
Storage
Requirements, expiration date (if applicable), etc.
Expired and/or un-labelled IP must be quarantined and not to be dispensed.
Explain expiration and retest dates to the subject.
The statement: "For clinical research use only" or similar wording
Siro Clinpharm initiative
www.siroinstitute.com
Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.
#Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune
#clinicalresearch #medicaldevices #career #opportunity #oncology
#safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing
#clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch # #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #pharmacovigilance #statistics #biostatistician #opportunity #interview #biostatistics #statisticalprogramming #team #fresher #project #students #development #projects #work #leaders #people #learning #culture #productivity #leader #event #clinicalresearch #clinicaloperations #clinicaldatamanagement #cdm
#clinicalresearchassociate #clinicalresearchcoordinator #pharmacovigilance ,#medicalcoders ,#sas ,#SASprogrammers #Biosatisticians, #Clinicaltrialdesign, #eTMF #lifescience
#medicaldevices,#scdmindia,#societyforclinicaldata
#lifesciencemanagement,#pharmaceuticals,#medicalwriting
#clinicalresearchinstitute #CRA #CRC #Databasedesign
#pharmacovigilanceindia #CTA #pharmacist #EDC , #GCP #pharmacovigilance #clinicalresearch #quality #clinicalresearchassociate #clinicalresearchcoordinator #clinicalresearchjobs #clinicaltrialmanagement #clinicaltrials #clinicaltraining #pharmacy #pharmacylife #pharmacycollege #pharmaceutical #pharmacist #pharmaindustry
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to KnowAnand Butani
A monitor in a clinical trial is also called a CRA - clinical research associate. This person is a professional who’s responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations, and good clinical practice.
Whether you already are a CRA or you’re trying to become one, the most important thing you should be aware of is the monitoring plan. You, as a CRA or a future CRA, should know what a monitoring plan is, what it serves for, and what it consists of. The second most important information for you are the monitoring visits. Below, we’ll explain all the components of a monitoring plan, as well as which are the most basic and important monitoring visits.
It contains the frequently asked question from users.
How HealthOnPhone is important for users. The security of system.
How they can access records from mobile app.
Data integrity - Regulatory Perspective and Challenges: santoshnarla
Data Integrity: Regulatory Perspective and Challenges.
This presentation will present the importance of data integrity in the pharma industry with regards to the quality compliance and its impact on industry. This presentation also emphasizes on importance of regulatory affairs department in ensuring the data integrity and regulatory challenges.
FDA Enforcement: What Every Clinical Director Should KnowMichael Swit
Half day tutorial presentation on key compliance concerns for those involved in clinical studies, with an emphasis on the key issues FDA examines and also a review of FDA's enforcement powers, ranging from warning letters to criminal prosecutions.
Adverse Drug Reaction (ADR) reporting is a vital process in pharmacovigilance that involves the identification, documentation, and analysis of adverse effects or unexpected reactions to medications. Healthcare professionals, including clinical pharmacists, play a crucial role in reporting ADRs to regulatory authorities. Timely and accurate reporting helps enhance patient safety, contributes to the continuous monitoring of drug safety profiles, and facilitates informed decision-making in healthcare. ADR reporting is a proactive measure to ensure the ongoing assessment and improvement of medication safety for the benefit of patients and the broader healthcare system.
Flaskdata.io automated monitoring for clinical trialsFlaskdata.io
In the race to deliver a COVID-19 vaccine, technology can be used to automate patient safety monitoring and assure that patients and physicians have valid data in order to make good decisions regarding risks and benefits.
Understanding the Drug Development ProcessEMMAIntl
The FDA’s process for drug development can be a lengthy, and often expensive, commitment. If you are developing a new drug product from the beginning, it is critical that you understand the phases of the development process and the deliverables for each. Beginning with R&D, you will have to ensure that your product corresponds with the FDA’s definition of a drug product. Next, it is advised that you conduct sufficient testing to get a baseline understanding of how your product works, what its intended use is, and other product specifications. Once you have completed this first step, you are ready to embark on the drug development journey...
Similar to Drug accountability: an important aspect of clinical research (20)
What to Do When There Are Adverse Events and Serious Adverse EventsTrialJoin
Clinical trials are experimental studies where the efficiency and safety of a new drug are being tested. For this reason, patients who decide to participate need to sign an informed consent form which states that they’re aware of the risks and benefits associated with the study drug or investigational product. With all this in mind, it’s expected that as some point, some patients will experience adverse events or even serious adverse events.
At the site level, it’s important to know what to do when this happens. What do you do when a patient experiences an adverse event? What do you do when it’s a serious adverse event? Whose job is it to deal with these cases? Who should report this and to whom? What should the CRA do? What should the PI and coordinator do? All of these questions are crucial in case of such situations.
New Drug Application - How to Speed Up FDA ApprovalTrialJoin
We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, what’s the purpose of it all? What happens after the trials end?
After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here we’ll discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved.
Negotiating Clinical Research Budgets: Most Commonly Neglected ItemsTrialJoin
As a clinical research site trying to get a better budget for a study, you need to remember that every item of a budget is negotiable. Being a good negotiator will allow you to get more out of every study you conduct at your site. In this article, we’ll teach you how to reach a win-win negotiation, as well as remind you of some of the most commonly neglected items in clinical trial budgets. Negotiating a budget is usually a long process and there are going to be many disagreements until you finally reach a mutually-beneficial deal, so continue reading and learning in order to achieve your goals and conduct a profitable study.
Most Common Clinical Research Site Worries and ComplaintsTrialJoin
All clinical research sites, especially new ones who’ve just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. We’ve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, we’ll give you answers to all your questions.
Explaining the Different Types of Routine Monitoring VisitsTrialJoin
In the clinical research industry, there are several types of basic monitoring visits that everyone involved in it should differentiate, especially CRAs (monitors). A CRA (clinical research associate) or a monitor is the person responsible for visiting a site in order to ensure that the clinical trial is being conducted properly. The CRA’s tasks include on-site visits and ensuring compliance, subjects’ safety, data quality and integrity, etc. Although clinical trials belong in the medical field, a CRA doesn’t have to be a doctor or a medical professional. It’s enough if a CRA has a background in Life Sciences, past experience in clinical trials (most often as a coordinator), and the proper training.
Essentials for Setting up a New Clinical Research CenterTrialJoin
This one is for all the doctors and medical specialists who are interested in opening up their own research clinic. As a doctor who’s interested in this option, we imagine that you’ve already seen a clinical research environment either by participating as a sub-investigator or a PI (principal investigator). If this is the case and you’re already familiar with everything that clinical research entails, then you’re in a good position to start your own clinical research center or research clinic.
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
Clinical Project Manager: Leading Causes of Problem Solving InefficienciesTrialJoin
A Clinical Project Manager (CPM) job is a high-rank position in the research world that many CRAs and investigators are aiming to reach. Being a Clinical Project Manager entails careful thinking, planning, and managing all features of a trial or study. The CPM’s role is to act as a middleman between the sponsor and the site. This means that he or she will be responsible for managing and leading CRAs and other site medical specialists such as PIs, sub-investigators, nurses, coordinators, etc.
Financing - Investigator Payment Models & Best Budget PracticesTrialJoin
Aside from being a vital part to medical advancement, a clinical trial is a complex and expensive business which requires great planning and strategy.
One big part of a successful trial are the finances. Financing clinical trials is a task that involves careful planning, anticipation, and negotiation of costs, budgets, and compensation to investigators. Taking into consideration the great number of items, procedures, protocols, subjects, and visits, it can be challenging to not miss or forget an item when you're preparing your budget. Managing to get the necessary budget that you need for covering all costs of conducting a trial requires careful anticipation and great negotiation skills. When negotiating your budget and explaining all the costs and expenses to sponsors, you have to take into consideration the costs for paying your investigators.
In this article, we'll explain all the different payment models for investigators as well as give you some great tips and techniques to help you allocate and negotiate your budget in a better way. Doing this will help you work with a profit, while still being able to cover all your trial expenses.
Legal Compensation for Referring Doctors in Clinical TrialsTrialJoin
As we all know, the best way for clinical research sites to recruit patients is through patient referrals. These referrals usually come either from the PI (principal investigator) or more often from other referring physicians.
Physicians who refer patients to your site can work independently or work as your sub-investigators. Now, when these physicians are your sub-Is you’ll have to find the proper way to compensate them. Many sites experience challenges related to sub-I compensation for referrals.
The way in which you choose to compensate these sub-investigators for referring patients to you should be legal and it shouldn’t interfere with “Anti-Kickback Statute” or the IRB.
So, how can clinical research sites do this? How do we compensate sub-Is in a legal way? We’re here to tell you that there are actually many ways in which this can be done. Below, we’ll give you the best solutions to this common problem.
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...TrialJoin
No matter if you’re reading this because you aspire to become a CRA, or you’re a study coordinator, or maybe you’re part of a research site, learning about feasibility surveys and questionnaires is important for everyone that’s in any way involved in clinical trials.
In this article, we’ll try to explain to you why feasibility questionnaires and site selection visits are important and how they can affect the sponsor’s decision of awarding you the study.
Regulating the Workload of Your Clinical Research Coordinator (CRC)TrialJoin
A CRC (clinical research coordinator) is one of the most important people regarding clinical trials. He/she is the person who’s in charge of conducting the clinical trial, under the guidance of the PI (principal investigator). As the people responsible for coordinating all the activities on site, CRCs can sometimes carry a huge workload. This can quickly become a big problem not only for the CRC but also for everyone else involved in the study.
Determining the right workload for your CRC is one of the most important actions that you (as a site owner or PI) should take. Ideally, a CRC should work 4 to 6 effective hours per day. However, you will notice that there will be periods of time when the CRC has to work more than 8 hours but also periods when he/she will be free most of the days. In this article, we’ll help you find the right balance so that your CRC isn’t too overworked or underworked.
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to KnowTrialJoin
A monitor in a clinical trial is also called a CRA - clinical research associate. This person is a professional who’s responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations, and good clinical practice.
Whether you already are a CRA or you’re trying to become one, the most important thing you should be aware of is the monitoring plan. You, as a CRA or a future CRA, should know what a monitoring plan is, what it serves for, and what it consists of. The second most important information for you are the monitoring visits. Below, we’ll explain all the components of a monitoring plan, as well as which are the most basic and important monitoring visits.
Differences Between Satellite Sites and Multi Site Research ClinicsTrialJoin
In the clinical research industry, there are two terms that we commonly encounter: satellite sites and multi sites. Although these two might sound the same, they’re not! The concept of a satellite site is much different than multi-site clinics. However, we can still see a large part the industry that is confusing these two terms.
Below, we’ll explain to you the difference between a satellite site and multi-site clinics.
Standard of Care Costs vs Study-Related CostsTrialJoin
In order for a study to be conducted properly, the sponsor and the site have to negotiate a fair and mutually agreeable budget. When we’re talking about budgeting for a study, there are many separate items and things to be considered.
One of the most intriguing points in a budget is the difference between Standard of Care costs and Research-Specific (study-related) costs. Clinical research is an area where it’s required that the sponsors disclose every dollar and every single amount which they pay to doctors they work with, and for this reason, calculating the standard of care costs is important when preparing the budget for a study.
Resolving Sponsors’ Objections in Clinical TrialsTrialJoin
In the clinical research industry, sponsors are the ones who fund every trial. These sponsors or CROs can be pharma or bio companies which invest large amounts of money for conducting research.
Sponsors will typically choose one or multiple research sites, depending on the size of the study and the required number of enrolled participants. One of the biggest concerns of all clinical research sites is being selected to conduct a study. Usually, after interested sites place a bid on a certain study, the sponsor will send a feasibility questionnaire to the sites he or she is interested in. After the sites fill out this feasibility report, the sponsor will choose one or multiple sites and go on a site selection visit. The site selection visit is the last step before you’re officially given the study to conduct. For this reason, sites should be especially attentive, make sure that everything goes as planned on these visits, and ensure that everything that the sponsor is going to see at the site fits the feasibility questionnaire they filled out earlier. The site selection visit is basically a confirmation that what you’ve stated in the questionnaire is actually true in practice.
However, no matter how much sites try to take care of every detail, sometimes the sponsor will still find an objection. When this happens, sites need to learn how to handle it properly and give the right answers.
Patient retention challenges and the best ways to solve themTrialJoin
As much as we want to say that patient problems stop with recruitment, this is usually not the case. In clinical research, many sites are able to recruit their necessary number of subjects, but then they start struggling to retain those patients until the end of the study.
Patient retention is crucial for the development of a study and for producing good data and results in the end. However, there are cases when retention becomes a challenge. This can happen for many different reasons, some of which can be prevented by the site and some not.
Seeing the high number of sites who face different problems with patient retention, we’ll give you an idea of what are the most common challenges you might face and how to fix them as much as possible.
Maintaining high levels of motivation and commitment of your clinical researc...TrialJoin
Clinical research projects usually have longer duration periods, so it’s not surprising that your research team can start losing focus and motivation after some time. Maintaining high levels of motivation, engagement, and commitment from the PI, coordinator, and all other individuals involved in research is extremely important for a successful project. This means that you will need to maintain the engagement of each individual separately as well as the whole team. Bringing back this focus and attention can sometimes be a big challenge for CRAs, sponsors or CROs.
Seeing how this problem is so common in the research community and how many people are constantly struggling with this question, we’ve decided to help you reach your best potential by showing you how to increase and maintain your team’s motivation and engagement in your research.
Increasing the quality of clinical research: best ways to solve the most comm...TrialJoin
Like many other businesses, clinical research also has its imperfections and inefficiencies. Clinical research involves many different parties: research sites, sponsors, CROs, PIs, CRAs, CRCs, patient recruitment agencies, etc. All of these parties play a significant role in the clinical research field.
As clinical research gets bigger and more evolved day by day, so does the need to fix the faulty areas. With the constant growing number of trials, the research industry urgently needs help!
Helpful information for sponsors: How to best spend your resources and avoid ...TrialJoin
Conducting a clinical trial as a business is equally important as it is expensive. Saying that this business is ‘’important’’ is actually an understatement, since clinical research is the stepping stone of all medical advancements and new treatments that can help millions of people worldwide. However, the importance of this business is proportional to its cost!
Clinical research is a costly business, and this can be best seen in pharma sponsors. Pharmaceutical companies are usually the ones that sponsor researches for new treatments. Estimations for 2013 show us that the average cost per patient in a clinical trial (all phases, all therapeutic areas) is $36,500. When we take this average number as an example and consider the number of sites a sponsor might need for the study, plus the necessary number of recruited patients (considering that most will not meet the criteria), we can see why this business is so expensive.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
2. Introduction
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.
2
3. www.trialjoin.com
What is an IP?
In clinical research, IP stands for
Investigational Product.
The investigational product is the product
that’s being tested - it can be either the
actual active ingredient or a placebo
(depending on the nature of the study).
3
5. Receiving the Study
Drug and IVRS/IWRS
Placing the IP in a Locked
Cabinet/Storage
The drug accountability process
starts even before randomization.
More specifically, it starts as soon
as the site receives the IP. Once the
drugs are received, the site
coordinator has to log in to IVRS
(Interactive Voice Response System)
or IWRS (Interactive Web Response
System), take the shipment
document, and manually check if all
the units stated in the document
are actually in the delivered box
(bottles, etc.) and that they aren’t
damaged.
Step
1
Step
2
www.trialjoin.com
Every research site should
have a locked cabinet with
the appropriate
temperature adjustments
for keeping the
investigational drug. So,
after making sure that all
the drugs delivered, place
them in your locked cabinet.
5
6. www.trialjoin.com
When it’s time to randomize the
subjects, log in to the IWRS, follow the
instructions on their website, and start
randomizing the subjects. After one
subject is randomized, the website will
give you a number which refers to the
subject’s number for the IP he/she
received on that specific visit. This
number should be then logged into
your IP accountability log in the
specific blank space. After this is done,
you (as the site coordinator) will go to
your drug storage/cabinet, find the
appropriate bottle/unit of IP
(according to the same number) and
give it to the subject.
Subject RandomizationStep
4
IP Accountability Log Step
3
After you’ve placed the drug
in the locked cabinet/storage,
you’ll fill out and keep an IP
accountability log in a
separate binder. Here, you
will manually enter every
number from every
bottle/unit of IP. After this is
done you will have a list with
all the units of IP. The rest of
the log will be left blank for
now because the product is
still not dispensed to
subjects.
6
7. www.trialjoin.com
The IP bottle/unit should
be returned to the site
regardless of whether it’s
completely empty or not.
Once the subject returns
the IP unit, you will enter
the number of returned
pills and the date they
were returned in your IP
accountability log.
Returning of the IP
Step
5
7
8. 01 02
06 07
03 04
0805
IP number of every
single unit/bottle
Date when the IP is
received
Date when the IP is
assigned to a subject
Which IP is assigned
to which subject
How many pills were
assigned to each
subject
Date of return of the
IP
How many pills/units
of IP were returned
IP that’s returned to
the sponsor/CRO at
the end of the study
and date
8
www.trialjoin.com
A filled out IP accountability log should give you the following information:
9. The Importance of Logging Data On Time
Maintaining and entering data in the IP log should
always be done regularly and on time. Many
coordinators forget to enter this data and when this
happens, it can really quickly become a huge mess.
After some time has passed, you won’t remember
which IP is dispensed to which subject. This will
make it really hard to keep track of the IP. For this
reason, it’s important to log in this data anytime
someone takes or returns an IP.
www.trialjoin.com
9
10. Close-Out Visit
When the study ends, it’s time for a close-out
visit.
On this visit, all your IP should be accounted for.
You should have a completely filled out IP
accountability log, returned (opened) bottles of
used drugs, and unused (closed) drug units that
weren’t assigned to any subjects.
The returned (used) units of IP and the unused
ones will then be shipped back to the sponsor
or CRO, and in the IP log you will fill out the
appropriate field for this.
www.trialjoin.com
10
11. www.trialjoin.com
CRAs and Drug Accountability
As we mentioned before, the CRA is only the monitor
of the study. This means that he or she is not
responsible for any of the steps explained above.
The CRA will be there to only monitor that the site is
doing this drug accountability and that they’re doing it
correctly and accurately. One of the most important
tasks of a CRA when it comes to drug accountability is
to make sure that the IP log is constantly and properly
maintained and kept up-to-date. After the study ends,
on the close-out visit, the CRA (monitor) will ship the
used and unused units of IP back to the sponsor or
the CRO.
11
12. FDA warning letters for drug accountability failures
Usually, the FDA will come for a drug accountability
inspection at your site. Here, they will check and
control if all of your drug accountability processes
and activities are accurate.
If they see that the site fails to comply with all drug
accountability rules and regulations, they will send
you a warning letter.
www.trialjoin.com
12
13. 13
www.trialjoin.com
Records of incomplete
and/or incorrect
distribution
An adequate
inventory of drugs
was not
maintained so now
records do not
identify recipients
of a particular
batch of the drug
There’s a lack of drug
accountability
registries in relation
to drug transfer
between sites
Not keeping records
of drug distribution
during the study
Shipping invoices
and dispensing
records that in
comparison show
more drugs being
administered than
originally received
You can receive an FDA Warning Letter some of the following problems have been found at your site:
14. 14
www.trialjoin.com
Issues between forms
of drug administration
and accountability
Non-availability of
dispensing drug
records
Study medication
that is missing or not
accounted for
Inaccurate and/or
inadequate source
documents
The CRO failed to
properly supervise
the clinical trial and
ensure compliance
or stopping of
unreliable clinical
investigators
You can receive an FDA Warning Letter some of the following problems have been found at your site:
15. www.trialjoin.com
CONCLUSION
To sum up, drug accountability is an important field in clinical research that will allow you to properly keep track of
every single unit of IP. By doing this task correctly and promptly, you will manage to save yourself a lot of time during
the close-out visit, avoid confusion, and improve data integrity and quality. Furthermore, remember that drug
accountability is a task that belongs to the site (usually the site coordinator), not to the CRA. The CRA will only be there
to monitor and make sure that you’re performing these tasks properly. And finally, the most important part of this
whole thing is the IP accountability log. Make sure to fill this out as soon as your IP arrives, and every time a subject
takes or returns the IP. Like this, you will have a clear and completely filled out accountability log which will provide you
with a better outlook on the whole picture. Drug accountability is one of the most important things in clinical research
since it can greatly influence the quality and integrity of study data and results.
15