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If you are in a country like Australia where PhDs are of limited duration, your university will have published procedures and policy regarding extensions and what is likely to be seen as a legitimate reason to request an extension. The James Cook University policy, for instance, states:2.1.3 An extension to the duration of candidature will not be not automatically granted, and requires the support of the Advisory Panel , the Head of the Enrolling Organisational Unit (or nominee) and the Dean, Graduate Research and must be negotiated and approved before its due date by the Variation of Candidature Form. The requested period of extension should be a maximum of six months.2.1.4 Extensions will not normally be approved retrospectively unless compelling circumstances that prevented the timely submission of the extension request can be demonstrated, such as sudden significant onset of illness.2.1.5 Candidates requesting an extension must be able to demonstrate convincing reasons for the delay in their candidature, e.g. significant disruption through illness or accident, unforeseen and unavoidable delays in obtaining information or data required or significant alteration to the research project and must provide a Gantt Chart outline.2.1.6 The Primary Advisor is required to estimate the likelihood of thesis submission in the requested extension period and in the case of a first extension period, in a second extension period.So you need to be able to demonstrate that the delay was unforeseen and unavoidable but that there is every reason to expect that you will successfully complete your PhD if you are granted the extension. Unforeseen and unavoidable delays may involve things like:Adverse weather conditions that disrupted planned fieldwork.Difficulty and delays in obtaining required approvals for sampling, animal experiments, or research involving human subjects.Chronic illness.Unforeseen new family responsibilities (though ideally this will be covered by taking a leave of absence at the time instead of requesting an extension later),Unexpected delays in obtaining materials or access to the equipment required for your research.Unforeseen experimental issues such as contamination of samples that required the work to be repeated, or finding that the planned method was not as practicable as expected in the field.Changes in health and safety procedures that meant you needed to refurbish the laboratory or obtain new qualifications before you could proceed with your work.Unexpected issues in the quality of the data obtained from a third party that required you to spend a lot more time than expected in data processing and QC.Unexpected features of the data that meant that the originally planned methods could not be applied and you needed to spend time developing a new method to handle the data.A change in your advisory arrangements that led to a change in your methods.New research published in the literature that had dramatic implications for your work and required you to re-evaluate your methods, objectives and/or interpretation of your results.So think carefully about the real reasons for the delay and try to explain them in a way that makes it clear that the delay was unavoidable and difficult to plan for.

There are several options you have and checkpoints you may go through, however it depends a lot upon how willing you are to go down any of these routes.First of all you should make it clear to yourself what your intentions are, and be coherent in why those subjects are important to you. If you want to for example keep music but the proposed timetable (or school rules) won’t allow for this, be stringent in why it is important for your preferred future career ie. The reason has to be more than you just “like it” or think you are “quite good at it”. If this already feels as though it could be too much effort or hassle, there’s little point in pursuing any protestations.Secondly, now you are clear in your preferred options present you views verbally and privately to your form tutor (or if you don’t have confidence in him or her being honest with you, verbally with another teacher you respect). Find out who it is from them that you want to put a formal request in for review in writing.Your proposals should not suggest an obvious, instead of maths or instead of english language choice, which will be dismissed out of hand. Losing one of the technologies, PE, the foreign language, RE, English literature, the social science, or proposing a single instead of double science, will depending on the school’s individual ethos and on the existing mandatory subjects chosen for you be far more considerable options. Note this varies, a religious school will be far more reluctant to you dropping RE / RS for example.Are you considered by the school to be a good or a disruptive student? Naturally if the former you are going to be starting on a far less sticky a wicket. If the latter and you are very serious about your subject options, now is the time to face a few home truths and swallow your pride a bit. By being willing to show a bit of give and take on that front, the school’s estimation of your maturity will improve, and the prospects of them taking your request to review options seriously will also greatly improve.Discuss with yourself the possibility of moving schools if you are really serious about this. Depending on your background and circumstances, seek clarification with a family member of a higher peer status on how they can support you.With that point considered at some point you will find out if your proposals have become accepted, conditionally accepted or rejected. If you receive one of the latter two responses, now you make it clear, with impartial witnesses present or recorded in writing that you are going to explore the option of studying elsewhere. You may well be doing this hoping to call their bluff, however if you have got this far and are still confident that you really want to do these optional subjects this is the time to act (Again if you are considered a good student, they will be far less likely to let you go as you are a “banker” on their GCSE statistics).Having shown maturity the school should in theory now be more honest with you. It may well be that another school is clearly the best option for you, and if you have gone down this road and that is the school’s finite conclusion, you should feel prepared to embrace that option. They won’t just cast you aside, you will receive support and guidance from someone, even if you feel one or two teachers to be petty.Don’t bad mouth the school and / or especially teachers or governors during the whole process, and keep things private to all but your closest and most-trusting of friends if you feel that you have to tell anyone. While you may find things frustrating, openly condemning processes before you have your fate sealed either way is only going to backfire if any repurcussions occur.My uncle was in a similar situation when he was 14/15, and ended up changing schools to do more technical and vocational skills which his more prestigious but academically-minded school did not offer on their curriculum, but he felt he needed in his preferred future career as an electrician. For him it was the best decision he ever made (though my Grandmother was highly against it at the time in a snobbish way).Equally I was in a comparable situation after my GCSE’s in year 11, and although things eventually turned out ok, I found all of this out the hard way. I wasn’t clear enough to my then school (which had a 6th form) why I wanted to go to the 6th form college instead to study what I wanted to (Spanish, German, and Music - of which they only would let me do one). They presumed I was bluffing and wanted to stay really, and was using all of it as a diversion tactic to get them off my back to study harder, and crucially I never put anything in clearly, calmly and in an official sense, however they also bluffed by greatly undervaluing to me my predicted GCSE’s whilst privately telling the 6th Form College what they really thought I’d get. The College then rejected me based on my likely staying on at my then school.I was, as one might guess, also a troublesome and mischievious student, and did not handle the situation well at times where I should have been honest and mature about things to all parties. I told my family nothing and they had presumed I had just got the subjects I wanted to continue at my school.To compound things I got even better results than anyone was expecting. The school had no choice but to accept me into the 6th form as I had no other place to go and good enough grades, but then the problem persisted in September that I was doing subjects that I hated. Worse was I could have done all three subjects now with my grades at the school, but the courses were already over-subscribed and it was too late. I left my school 4 days into the year, and was wiling to live with other relatives by this point to do what I wanted to do. I went down to the 6th form college the same day, and spoke with the head of foreign languages at the college that afternoon. We spoke in German for 10 minutes and I was enrolled on the courses. He then said that had I been upfront and honest to the 6th form, and contacted them sooner, they would have jumped at a student wanting to do my courses and I would have saved myself 6th months of lying, stress and bluffing to everyone around me.So don’t do what I did, I was very lucky, and a bit of a dick. I now work in a College and come across similar circumstances on occasion, some having followed the mature approach, and others what was my one.

Developing a clinical trial budget can be a confusing exercise for sponsors and CROs. There are too many cost variables to account for.This post covers the key cost drivers for medical device clinical trials. If you are a researcher or financial analyst working in clinical trial space or simply curious about clinical trial costs, this post will serve you well.So let’s get started.1. PATIENT GRANTPatient grant costs are broken down into screening, baseline and follow-up visits and medical imaging costs.A. SCREEN FAILURESClinical trial protocols have inclusion and exclusion criteria to qualify patients. Strict inclusions and exclusion criteria reduce the available patient pool for trial enrollment. Clinical sites spend physician and site coordinator time to screen for potential patients.During the budgeting process, map out the complete patient screening workflow. Speak with a few clinical sites to understand how many patients they would have to see in order to find one qualified patient. For example, a site may need to screen four patients to find one qualified patient. Understand how many hours the site is spending on screening activities and reimburse accordingly. It is not unusual to reimburse sites anywhere between $50 to $250+ per screen failure.B. BASELINE/INDEX PROCEDURE AND FOLLOW-UP VISITSDepending on the clinical trial design, data is collected at baseline/index procedures and follow-up visits. The site coordinator is generally responsible for entering the data in the case report form. Sites are reimbursed for the time spent to collect clinical trial data.Based on number and type data fields you are collecting, you’ll want to estimate the site coordinator time needed to collect and input trial data. Multiply the estimated coordinator time by the hourly bill rate to obtain the fair market value for each patient visit.In some cases, sponsors may choose to reimburse patients. Reimbursement for patients can include paying for their participation, reimbursement for travel, meals or overnight hotel stays.C. NON-STANDARD OF CARE TESTSMedical device trials may require non-standard of care tests such as medical imaging scans. These costs are generally not reimbursed by insurance companies or medical care agencies and should be budgeted as part of the clinical trial cost.D. PROCEDURE COSTSIf the clinical trial procedure is reimbursed, you don’t need to budget for the procedure cost. Insurance or medical care agencies will pay for the procedure. In case a brand new procedure where no reimbursement available, budget for the procedure costs.2. SITE COSTSA. START-UP FEESClinical sites spend significant time to initiate a new clinical trial. Sites are responsible for site specific informed consent development, Ethics Committee (EC)/ Investigational Review Board (IRB) submissions, staff training including participation in investigator/ site coordinator meetings and site initiation visits and execute a clinical trial contract. It is typical for sponsor to pay anywhere between $2000 – $5000+ in site start-up fees.B. EC/IRB FEESEC/IRB fees are in addition to site start-up fees. These fees cover the time spent to by EC/IRBs to plan and conduct review of the clinical trial protocol and other associated materials. Many EC/IRBs update and publish their rates annually.C. CLOSE-OUT FEESClose-out fees include time spent by site staff to reconcile clinical trial data, finances and regulatory documents during study closure. Not all sites require this payment but has started to become a more common practice in recent years.D. STORAGE FEESGovernment regulations require that clinical trial data be stored after study close-out. The duration for storage can range from 2-years to permanent storage. It is not uncommon for sites to have boxes of regulatory paperwork that needs to be stored once a clinical trial ends. The storage fees vary by country and site.Some sponsors make arrangements for site to send trial documents to an offsite storage location. Due to country specific regulations, a site might be unable to move documents outside their country.E. ADMINISTRATIVE OVERHEADClinical sites may require as much as 30% administrative overhead in addition to per patient grant amount. This cost covers management and legal resources needed to provide clinical research oversight and legal review of clinical contracts respectively.F. SITE MANAGEMENT ORGANIZATION (SMO)In certain countries such as Japan, data entry and collection tasks are outsourced to SMOs. For post approval studies, sites do not research coordinator support. Sponsors are expected to hire SMOs to support the site or pay the sites to hire their preferred SMOs.3. NON-PATIENT COSTSA. CLINICAL EVALUATION COMMITTEE (CEC)Adverse event and endpoint data is adjudicated by a non-biased, independent CEC. CEC is generally composed 3 or more physicians. CEC members review adverse events and trial endpoints in a team setting or independently.A sponsor can hire physicians to serve as the CEC and reimburse them at fair market value rates. It is more cost effective for sponsor to contract with physicians directly. However the sponsor has to assign its own resources to manage the CEC.The other option is for the sponsor to outsource management and conduct of CEC activities. This option is more expensive because you are hiring professionals to manage the CEC.CEC is a very important component of medical device clinical trial. Adjudicated adverse event data is highly regarded by regulatory agencies and the physician community. In many cases, it is a requirement to have adjudicated adverse event data in order to get the product on market.B. DATA SAFETY MONITORING BOARD (DSMB)DSMB is also known as the Data Monitoring Committee (DMC). According to IMARC research, the purpose of the DMC is to advise the sponsor on continuing safety of the trial subjects and those yet to be recruited and provide continuing validity and scientific merit of the study.For budgeting purposes, it is important to know that DSMB is required during trial enrollment phase and in some cases till all patients have reached their primary endpoint. The decision of whether or not to conduct DSMB meetings after the primary endpoint is reached, is up to the sponsor.C. PHYSICIAN CONSULTINGPhysicians are consulted during all phases of a clinical trial. Physician guidance is needed to develop clinical trial strategy, enrollment plan, final data analysis and publication plans.Depending on the physician’s medical expertise and geographical location, consulting costs can be anywhere between $150 – $600+ per hour. If a clinical trial is interesting to the physician, he or she may be willing to provide consulting services at no cost.D. INDEPENDENT CORELAB ANALYSISMany medical device trials collect imaging data such as angiograms, CT scans and X-Rays. Since this data comes from multiple sites, variability is expected. An independent corelab standardizes the collection and analysis of imaging data.Corelab costs can add up quickly. Costs depend upon the number of images analyzed per patient, the time it takes for the corelab to analyze the data, and the duration of the trial.Corelabs usually hire analysts to collect and calibrate data from different sites. The final analysis is usually done by a physician. Given the complexity of imaging data collection and analysis combined with the importance of corelab data to regulatory agencies, it is important that adequate and accurate budget is allocated for independent corelab analysis.E. MEDICAL DEVICE COSTOnce you are ready to enroll patients in the clinical trial, you’ll need to ship medical devices to the sites. Most sites will expect to receive these devices for free. The only exception is when conducting post approval trials for commercially available devices.Medical device manufacturers conduct trials for indication expansion. For example, a stent company may conduct a trial to get their heart stent approved for use in a different anatomy. For such expansion trials, sponsors may need to provide commercially available devices to sites at no cost.Whether or not you want to provide devices at no cost is a business decision. When investigational medical devices are provided at no cost, sites enroll faster and have a much stronger, collaborative relationship with the sponsor.4. LABOR COSTSIn order to conduct a clinical trial, you need to hire people that have expertise in clinical research and clinical trial management. Depending on the size of the trial and the number of trials conducted, resource allocations vary. Therefore amount of labor needed to run a study also varies.A. CLINICAL RESEARCH ASSISTANTS OR ASSOCIATES (CRAS)CRAs are primarily responsible for monitoring clinical trial data that is collected during the course of the study. They visit clinical research sites to ensure data is collected in a compliant manner.B. PROJECT MANAGER (ALSO KNOWN AS CLINICAL TRIAL MANAGER OR STUDY MANAGER)A project manager’s responsibilities can vary from one organization to another. Project managers are like “general contractors.” A project manager is responsible for managing the clinical trial budget, resources and timelines. The core function of a project manager is to resolve or escalate issues that come up during the course of a clinical study.C. DATA MANAGERA data manager’s job is to address data discrepancy issues by generating queries to sites. Data managers may also be responsible for implementing electronic data capture system or paper case report forms needed to collect trial data.D. SCIENTISTThe scientist is primarily responsible for developing the clinical strategy for a trial. Individuals with Ph.D. or M.D. degrees are usually the right fit for this role. In some organizations, the project manager also play the role of the scientist.E. BIOSTATISTICIANA biostatistician is responsible for developing a statistical analysis plan (SAP). The SAP documents on the data will be analyzed during the course of the study. A statistician or statistical programmer is also responsible for programming data tables that are incorporated in the final clinical study reports.F. QUALITYClinical research is a regulated industry. Quality plays an important role in ensuring sponsors, CROs, and clinical sites are conducting the trial in a compliant manner. A quality associate or manager helps an organization create and implement standard operating procedures (SOPs).Salaries for these roles can vary by geography and experience. The above list is not comprehensive. However it should give you an idea of the core resources needed to conduct a medical device clinical trial.5. SITE MANAGEMENTA. PRE-STUDY VISITSPrior to inviting any site to participate in a clinical trial, you want to conduct pre-study visit, also know as the site assessment visit. This visit becomes even more important if you don’t have any prior experience working with the site in a clinical or commercial setting.Although sites don’t charge for this visit, the sponsor will need to pay for travel and CRA labor costs.B. SITE INITIATION VISITS (SIV)Once the site has received Institutional Review Board (IRB) approval and the trial contract has been signed, it’s time to activate the site for patient enrollment.A SIV is conducted once you are ready to activate the site. SIV involves training the site on the clinical protocol and any other study-specific requirements.Similar to the a pre-study visit, the sponsor will need to pay for travel and CRA labor costs.C. MONITORINGOnce patients are enrolled in the study, you want to ensure data is collected in a compliance with regulations and the clinical study protocol. This is when monitoring comes into play.A CRA, sometimes known as the site monitor, visits clinical sites at regular intervals to ensure compliance.In recent years, due to push for reduction in clinical trial costs, several sponsors have started to monitor remotely rather than conducting an in-person monitoring trip.D. CLOSE-OUTOnce all patients at a site have completed their follow-up visits, it’s time to conduct a close-out visit. Any open items related to study conduct are addressed during the close-out visit.Although it’s always nice to have in-person close-out visits, it’s acceptable to close trials via remote close-out calls.6. MISCELLANEOUSA. INVESTIGATOR MEETINGSInvestigator Meetings usually serve to kick-off a new clinical trial. Investigators and research coordinators participating in the study are invited to participate in a 1-2 day meeting. The purpose of these meetings is to educate site personnel on the clinical trial protocol and any other specific trial requirements.These meetings can be quite expensive as airfare, hotel and meals are usually provided by the sponsor.B. TRAVELPlan and budget for adhoc travel. Since clinical trials are heavily regulated, you may need to visit a site to address a compliance issue or help them prepare for an audit. In other cases, you may want to visit a site to motivate them to enroll patients. Whatever the case may be, it’s always good to have some money set aside for travel.C. DOCUMENT TRANSLATIONSDocument translations costs can increase significantly depending on the countries in which the clinical trial is conducted. Sites where English is not the primary language, you may receive request for translation of key documents such as the protocol and site specific informed consent in the local language.Also if the adverse event source documents from non-English speaking sites are in their native language, additional costs will incur to translate documents into English for event adjudication purposes.D. TECHNOLOGY SOLUTIONSClinical Trial Management System (CTMS), Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), Interactive Voice/Web Response System are a few common technology solutions implemented when conducting a clinical study. These systems are needed to manage site contact information, collect clinical data and maintain clinical trial records. There is a monthly or annual license fee associated with these systems. Additionally staff is needed to manage and maintain these systems.E. REGULATORY FILING FEESRegulatory filing fees should not be overlooked as these can run into thousands of dollars. Depending on the class of medical device, different applications need to be filed with regulatory agencies, competent authorities and notified bodies.7. OTHER FACTORS:A. PROTOCOL AMENDMENTSDue to unforeseen circumstances, a clinical protocol amendment may be necessary. A protocol amendment has many downstream effects that can increase the cost of a clinical trial.A protocol amendment usually leads to additional IRB/EC fees, site costs, regulatory re-submissions and more.B. INFLATION, VALUE ADDED TAX (VAT) AND FOREIGN EXCHANGEInflation should be factored in for multi-year clinical trials. In the US, a minimum 3% inflation is expected.Sites in countries such as Australia and Europe, add VAT for the research services. VAT can be upwards of 12% on all research services.For trials conducted in multiple countries, paying attention to foreign exchange rates. At a minimum, annual review of exchange rates is advised. Clinical trial cost projections should be adjusted based on exchange rates.C. TRIAL ENROLLMENT DELAYSEnrolling in trials is tricky business. It takes longer to complete enrollment and initial projections are overly optimistic. Account for these delays when you develop your clinical trial budget.[1]To summarize, you should now have a solid understanding of these factors that impact clinical trial costs:Patient grant amount such as screen failure costs, data entry costs and travel reimbursementSite costs such as site start-up fees, EC/IRB fees, close-out and storage feesNon-patient costs such as core labatory fees, clinical events committee and data safety monitoring boardLabor costs – clinical research employee salaries or contractor paymentsSite management costs such as pre-study, site initiation, monitoring and close-out visitsMiscellaneous costs such as travel, technology solutions and regulatory filing costsOther factors such as value added tax, inflation, protocol amendment and delays in enrollmentFootnotes[1] Ultimate Guide to Clinical Trial Costs - Clinical Trial Podcast