What is the IMV lead candidate?
What is the Vitalize study?
What is phase 1 of DPX-RSV?
Does IMV have expanded access to drugs?
What does IMV mean in clinical research?
Interim Monitoring Visits (IMV's), also referred to as Routine Monitoring Visits are the most common type of Monitoring Visit that a site will have.
What is interim monitoring visit?
Interim Monitoring Visit: A visit conducted by a CRA to review source documents and study related materials and to ensure protocol and regulatory compliance. This visit takes place during the conduct of the study.
What is a site initiation visit?
A Site Initiation Visit (SIV) or Study Start-Up is an organized meeting to discuss the new protocol before the research project is ready to screen and enroll potential patients. It also serves as training for the protocol of interest.
What is a TLF in clinical trials?
What is a TLF? Tables, listings, and figures are what are used when writing the Clinical Study Report (CSR), publishing results on ClinicalTrials.Gov, and developing the package insert for approved products.
Why is interim monitoring important?
It ensures patient safety and that study progress and conduct are appropriate, and it allows the study early determination of efficacy/effectiveness. An essential component of interim monitoring is the use of independent monitors or DSMBs.
How many types of monitoring are there in clinical trials?
Study sites are monitored to ensure oversight of the clinical research study by the sponsor. Regular site monitor visits can be broken down into four types: pre-study visits, initiation visits, periodic monitoring visits, and close-out visits.
What happens after site initiation visit?
Once the site is initiated, it is important that the research team notifies all parties involved in the study. Internal supporting ancillary departments may require subsequent kick-off meetings to discuss study logistics.
Is a site initiation visit mandatory?
The Site Initiation Visit (SIV) is required to prepare and set up a research site to conduct a study and must occur prior to patient recruitment. The principal investigator (PI) must attend this visit together with as many members of the research team as possible.
Who attends the site initiation visit?
All study staff responsible for the implementation of the study will attend the initiation visit. This typically includes the PI, co-investigator(s), study coordinator, research nurses, and/or other study staff who will interact with participants, as well as data management staff.
What is clinical trial ETD?
The study will have 3 aims....Official Title:Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory PressureActual Study Start Date :August 11, 2020Estimated Primary Completion Date :July 1, 2025Estimated Study Completion Date :July 1, 20257 more rows•May 27, 2020
What is MVR in clinical trials?
MVR stands for Monitoring Visit Report (clinical trials)
What does SSU mean in clinical trials?
Study start-up (SSU) for randomized controlled trials is usually a long and costly process that can cause significant delays. Addressing this challenge, CTTI conducted work to identify specific metrics and benchmarks related to SSU, recommending greater standardization within the clinical trials ecosystem.
What is a monitoring visit?
Monitoring visit means an announced or unannounced visit made to a residential child care program by department personnel for the purpose of assessing compliance with the standards set by rule adopted by the commissioner pursuant to RSA 541-A.
What should be included in a monitoring procedure?
Generally, monitoring procedures are needed to measure the concentration of the fluid and its functional components, the concentration and effect of the various materials that may contaminant the fluid, and in-process checks of fluid performance (e.g., tool life, corrosion protection).
What does monitoring mean in clinical trials?
Monitoring is defined as the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, The Principles of GCP, and the Medicines for Human Use (Clinical Trails) Regulations - where applicable.
What is the purpose of monitoring a clinical trial?
The purposes of clinical trial monitoring are to make sure that: The rights and well-being of human participants are protected. The reported trial data are accurate, complete, and verifiable from source documents (records of clinical findings, observations, or other activities in a clinical trial).
IMV Announces First Patient Dosed in Phase 1b Clinical Study Evaluating ...
For the first time, maveropepimut-S is being evaluated in a neoadjuvant combination and in patients with breast cancer. Primary results of the study are expected in 2023
Maveropepimut S - IMV - AdisInsight - Springer
Subscriber content You need to be a logged in subscriber to view this content. If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely. IP authentication when working within your organization’s network.
Site Initiation Checklist
For studies NOT involving Investigational Medicinal Products or Devices (i.e., Non-CTIMP studies) Page 1 of 6 SOP S-1011 Appendix 7 Non-CTIMP Site Initiation Checklist & Outstanding Issues Report v1.1 Sept 2021
Types of Clinical Trial Site Visits - CRA - Clinical Research Info
A CRA could be employed directly by the sponsor companies (Pharmaceutical, Biotechnology or any research company) of clinical trials or by Contract Research Organizations (CROs) also referred to as Clinical Research Organizations (As per ICH GCP) that conduct clinical trials on behalf of the sponsor companies.Let’s learn about the types of clinical trial site visits conducted by CRA.
PRE STUDY SITE VISITS (PSSV) SITE INITIATION VISITS (SIV)
Central Manchester University Hospitals NHS Foundation Trust Copy no: electronic Q-pulse Laboratory Medicine Version: v1 – PSSV/SIV (Trial Coordinators)
What is the IMV lead candidate?
IMV’s clinical-stage cancer programs are evaluating the use of our lead candidate, Maveropepimut-S and oral intermittent low dose of cyclophosphamide (an immunomodulatory agent) with and without Pembrolizumab, Merck’s checkpoint inhibitor.
What is the Vitalize study?
The VITALIZE Study is a Phase 2 clinical trial that evaluates Maveropepimut-S in combination with the checkpoint inhibitor Keytruda® (pembrolizumab) from Merck in patients with recurrent, refractory diffuse large B cell lymphoma (r/r DLBCL).
What is phase 1 of DPX-RSV?
This completed phase 1, First in Humans, randomized (2:2:1) observer blind, controlled, dose ranging, multi-arm parallel-group clinical trial in healthy persons 50 to 64 years of age to assess the safety and immunogenicity of two dose levels of a novel vaccine formulation DPX-RSV (A) consisting of a synthetic Respiratory Syncytial Virus SHe antigen combined with a novel adjuvant DepoVaxTM, compared to the antigen combined with the commonly used adjuvant Aluminum hydroxide, and to a saline placebo control.
Does IMV have expanded access to drugs?
Expanded Access to Our Therapies. In some circumstances, IMV is able to offer access to our investigational drugs (drugs not approved by regulatory agencies) to patients who cannot access the treatment through clinical trials.
What is IMV medical information?
IMV Medical Information Division, part of Science and Medicine Group, is a marketing research and consulting firm founded in 1977, specializing in medical imaging and other advanced healthcare technology markets.
When was IMV founded?
Founded in 1977, IMV is a recognized leader in market research and online publishing for the medical imaging and clinical diagnostic instruments markets.
What is a follow up letter for IMV?
Correspondingly, a Follow-Up Letter, which is very similar to a Confirmation Letter and equally as important, should be sent to the site to summarize the IMV and what was accomplished. Any and all new or unresolved action items and/or findings will be listed as well as updates to enrollment such as newly screened and randomized subjects. The next tentative IMV will be listed with a projected date that is subject to change. One of the more important things will be the description that notes if there was a meeting with the PI. This is important because it gives insight into PI oversight and availability as well as involvement and is something that can be frowned upon or subject to investigation by the FDA or Sponsor if it is determined that there may not be adequate oversight of the trial. All things considered, the Follow-up Letter should accurately depict the IMV.
How often does a CRA perform SDV?
First, Traditional Monitoring is the most commonly used strategy and has been widely utilized for decades. It is where a CRA will simply visit a site every 4–6 weeks based on enrollment activity and perform 100% SDV (Source Data Verification) while picking up where he/she left off from the previous monitoring visit. Each site visit will be conducted using the same processes by the CRA, the only variable being the frequency of visits which will be determined based on enrollment activity. As expected, a site with greater enrollment activity will be visited more often while sites with low activity will have more time in between each monitoring visit. After SDV is performed, the CRA will then look through the documents in the regulatory binder to confirm that they are there and hold up to ALCOA standards with whatever time may be left over for the visit. Some of the disadvantages to this strategy are that to perform 100% SDV, there may be little to no time left over for proactive activities such as going through the regulatory documents and conducting other essential parts of the visit such as further protocol training, in depth meetings with the PI, helping with recruitment strategies and/or providing the necessary tools for a site to be more successful.
Can CRA view SDV?
With the Introduction and help of Remote Monitoring Visits, a CRA can now view sources and complete SDV via virtual workspaces such as Intralinks instead of having to perform this function on site, leaving much more time for the activities that are typically overshadowed by SDV in the Traditional Strategy of Monitoring. Remote Monitoring is not to be confused as a standalone strategy, it is a tool to be used in conjunction with Risk Based and/or Traditional Monitoring based on the given sites’ risk profile.
What is the CRA role in a SIV?
The CRA will typically be assigned to a monitoring room by the CRC to set up anything pertaining to the completion of the SIV. Most often, and even more so with newer sites or inexperienced staff members, there will be pending action items for the site to complete and it is important for the CRA to guide the site in the correct manner to achieve the completion of anything that needs to be done before that site can be activated. It is also helpful to remember that all CRA’s have different processes and preferences, the order of which is subject to change depending on what they feel is the most important to review first on a site-by-site basis.
How to release medical records?
Medical records, if applicable, should be released by the subject via a medical records release form . These records are wanted by sponsors for most trials but the reality is that they cannot always be obtained; with this in mind, sponsors (and Good Clinical Practice) have required that for most trials as long as three separately documented attempts have been made to gather a subject’s medical records, that is sufficient enough. Although this may not be true for all trials which require medical records as part of the inclusion criteria due to specific diagnostic information that is needed for subject randomization. Some acceptable forms of these attempts include but are not limited to fax confirmations and documentation of telephone calls made. This process is to be completed by the site within the screening visit window.
What is CRA in clinical research?
Clinic al Research Associates (CRA’s) can and will recommend a site depending on their personal past experiences with the site; this may be due to the overall work ethic, professionalism, enrollment capabilities etc of the site.
What is a clinical research associate?
A Clinical Research Associate (CRA) is a liaison between the site and sponsor, dedicated to focusing on the needs of both to be able to give feedback and provide suggestions while maintaining Good Clinical Practices (GCP’s). As a CRA, it is imperative that before anything occurs, a great working relationship is created with the site in order to eliminate any fear of communication and become more efficient as well as productive. This will encourage the site to ask questions and verify certain statements that the protocol or sponsor may be ambiguous about, therefore, eliminating any unnecessary errors and/or deviations and keeping surprises during Interim Monitoring Visits (IMV’s) to a minimum. Establishing this kind of relationship will prevent resistance and help to nurture the success of the site, the CRA, and ultimately the goals of the Sponsor. With that being stated, source documents can be discussed.
What is the IMV lead candidate?
IMV’s clinical-stage cancer programs are evaluating the use of our lead candidate, Maveropepimut-S and oral intermittent low dose of cyclophosphamide (an immunomodulatory agent) with and without Pembrolizumab, Merck’s checkpoint inhibitor.
What is the Vitalize study?
The VITALIZE Study is a Phase 2 clinical trial that evaluates Maveropepimut-S in combination with the checkpoint inhibitor Keytruda® (pembrolizumab) from Merck in patients with recurrent, refractory diffuse large B cell lymphoma (r/r DLBCL).
What is phase 1 of DPX-RSV?
This completed phase 1, First in Humans, randomized (2:2:1) observer blind, controlled, dose ranging, multi-arm parallel-group clinical trial in healthy persons 50 to 64 years of age to assess the safety and immunogenicity of two dose levels of a novel vaccine formulation DPX-RSV (A) consisting of a synthetic Respiratory Syncytial Virus SHe antigen combined with a novel adjuvant DepoVaxTM, compared to the antigen combined with the commonly used adjuvant Aluminum hydroxide, and to a saline placebo control.
Does IMV have expanded access to drugs?
Expanded Access to Our Therapies. In some circumstances, IMV is able to offer access to our investigational drugs (drugs not approved by regulatory agencies) to patients who cannot access the treatment through clinical trials.