A protocol is a documentary that will include information such as how many days and how many patients we are recruiting, as well as other considerations. While reading the procedure, the first thing you’ll notice is the title. Every protocol has this title; perhaps you can use a different title. It is an 8-week double-blind, randomised, multicentre, parallel group active controlled trial that compares the safety and efficacy.
Drug 450 MG is a medication. 150 MG 75 MG So the title is “two compared to 5 MG in patients with essential hypertension.” It is an 8-week double-blind randomised parallel group. So more than double in an eight-week period. This indicates that the entire study will take eight weeks to finish. That means patients might be admitted to the hospital as early as day 1-2 and stay for up to 8 weeks. Only he’ll be admitted to the hospital and may need to take the medication for up to 8 weeks. Double-blind indicates that even the patient is unaware of the medicine he is taking. Even the investigator is unaware of the medicine he is administering. This is a blinded study. Double-blind randomisation means that they are assigning that specific medicine to that specific number of patients. Perhaps they have recruited 13 to 1400 persons or something along those lines. They will prescribe a medication. We need to randomly allocate to all of them, so they’ll just allocate with it and the goal of the study, and so they’ll see that it’s in a multicentre, and they’ll run this particular clinical trial at a different hospital. So here is your multi-centre clinical trial parallel group, what is a parallel group, and what is a crossover design. Parallel group indicates that for two weeks, say eight weeks, we’re giving ex drug to A and why drug to be even the same for this one, so maybe at some point we need to replace it. The term “parallel” refers to the clinical trial’s beginning to end. The person has not altered as a result of any drugs.
Assume that the person has taken a drug in the past and that the person is still taking drugs in the industry. Then we name that particular type of design a research design. If the person began as a, we refer to it as a parallel study. A drug was initially added as an extra, but over the next four weeks, he switched to why drug. Then we call this type of study a crossover design. So, it’s currently a parallel investigation. As a result, there is no crossover into your factors, such as a therapy. as in a treatment Group One treatment group, periods 1 and 2.TRT 01, TRT EUR 2 year, and everything else is just a phase. Period denotes 1-2. The first 2-4 weeks will be period one and four two. The next four weeks will be quite difficult. So TRT 01 year means that all treatments will be the same as before. PRT O2 year indicates that beginning on the 4th, we will chat about whatever treatment they are receiving. Taking it, it will fall under that specific variable. You should be able to get it in the.
. active controlled study that means in this particular there will be active drug and there will be a comparative drug also. So basically, they want to cheque that this particular drug farm G is much more powerful than this. this particular three drugs are much more powerful. And these drugs which is there in the market right now which is there here like a, they have tested one drug and with a different dose like a 450MG dose, 150MG dose and 75 MG dose which one is working more powerful, we want to see that. So, if you want to get those details which Rose is working more powerful when comparing with the already existing drug which is there in the market. So is it 450MG is working more than your family drug which is there in the market or else 150MG drug is working more powerful than that are maybe 75 MG is it’s enough working more powerful. So, we’re just comparing it on the patients who are suffering with essential hypertension. So, the title will tell you that about your clinical trial process. Maybe the total study. It’s an 8-week double-blind randomised parallel group active control study comparing the safety. Safety means how save the drug is generally. How safety will be measured whenever certain injection has given to UR, maybe certain tablet has given how save UR after taking that. maybe the drug is working or not working. We’re not very. First of all, how safe you are? You are getting any stomach acidity after taking the pill or you are getting any headache after taking the pill and that will be measured. In the safety and all we effect to that is that means to because of this particular drug. they want to identify this particular drug is coming under cardiology study or working on it. The study purpose is very simple. All this particular analysis you are mainly doing it to get an approval of this particular drug by the market that is a purpose any clinical trial, the purpose is very simple to get approval from the FDA are maybe that local regulatory? Body whatever it is to get the approvals so they will do this. All this a clinical trial that is purpose. Another key important thing you need to keep in mind while reading the protocol is what is the primary object to us why they want to do this clinical trial. What is the key primary object to it is what it is you need to. That will be different from protocol to protocol. What is the primary object to sign that particular clinical trial? What is the secondary object to send a pre-clinical trial? It is very important what is the title of that particular protocol? What is the purpose? What is the primary object to So, you need to be ready with that particular what is the primary object to and what is a secondary object to end all and apart from that populations We will get it per protocol set population if you want it and analysis, full analysis, set population are maybe safety analysis. Set population like a different population sets what needs to be created. They’ll also mentioned in your protocol how you derive it and. Will be returning or Spec. so spec will begin designing based on your SAP only statistical analysis plan. So, statistician will take a protocol as a source to develop SAP is the source for your developing of your analyst’s data set specification or SDTM data specification. His inclusion criteria as an exclusion criterion who are all included. Suppose imagine if you’re recruiting around 1500 members, although 1500 members will not be participating in the clinical trial, few few members maybe they get eliminated or may be removed from this particular clinical trial that we call it as an inclusion and exclusion criteria. How many? Are included in this clinical trial. How many are excluded are how many are enrolled how many are those has given that means it’s the safety population setting. like that all the details you can able to get it by just using this particular inclusion criterion’s closing criteria and all and apart from that the key thing you need to understand is how the doses has given. And when you are asking a patient to come to the hospital total eight weeks of tidy study, we just say we are asking patient to come to the total 8 weeks, within this particular duration when the first time came to the hospital category one and watch out, watch out means we are allowing a patient to what I can say just alone not to take any. Maybe just imagine the patient is already suffering with DPR, maybe hypertension, he may take some medications. So, what we do is wash out means we are allowing that particular patient not to take any medication until our clinical trial washout period means we are allowing the patient not to take any medication by the time what happens, you know? Is there any medication is already in his body so that will be get excreted from the urine or maybe from the sweater, maybe from the tools and it will be get excreted from the body so that. So, we will allow that particular time that we call it as a wash out and a single blind means will try to give this particular drug so that is a single blind drug to patients. So that why the single blind things we will do is to really cheque that the patient he is is lying or he is really responding to that particular drug and all to cheque it. We just do a single blind. Also, we do double-blind treatment. Also downloading treatment means exactly these drugs will give it in this particular time. So, and the visitor you can see that this all the clinical trial of total eight weeks of study is divided into What is informed consent? That means the person is signing that he is. Ready to taking the medication. so that’s the reason why he’s signing on the document, so that he’ll fill this particular form called informed consent form. And we’re coming to the two. It is nothing but an exclusion and inclusion criteria. Persons will check. That is the particular person is included or excluded. Actually this inclusion, exclusion criteria, they’re doing it when the person is.Coming to the hospital for the first time and as well as the person is coming to the hospital second time also the person is coming to the hospital thought time and for that I’m also they’re just checking ETA is that particular person is eligible to take the medication and not once the person is taking a medication they will not cheque including next room criteria one more time cause the inclusion exclusion criteria is required until taking the medication. Is there any medical history or per patient who can see that medical history when the person has a giving that demographic information and medical info, military information, demographics and medical history, we will collect it only one time only One patient for one record only is possible in your demography, but your medical history you will have. Impatient for multiple records, let’s say demographic information. We said that to take it on first time so that we will ask that person data, birth, sex, raise, ethnicity and all. We will take it under demography. Medical history will take data. Is there any medical history happen that means you are already suffering with any cancer or maybe you are suffering with HIV are maybe you’re suffering with. Some gastric problems or any of those things. So, we will just record that it comes under medical history how many times particularly is capturing in according to this particular clinical trial, It’s just only one time. You can see it here in your data right now so. Let me wipe off everything. So, one time the medical history they’re just a collecting it here and apart from that so you can see that every examination easy how many times they are taking it at this into marks is nothing but a as the patient has come to the hospital total six times. . within those each six times how and what type of information there. Collecting it are you can able to get it on the assessment schedule table. So, in the protocol you need to must know about what is the title of the study and we also call this particular name it after what is the study design. Also, we call it as A and study purpose and the primary object to our primary object to solve that particular clinical trial. What is the secondary objective of the clinical trials? What are the different populations we need to derive in this particular clinical trial and what is the inclusion criteria to what is exclusion criteria and as well as assessment schedule like on this particular total eight weeks of Imagine the same patient, we have two times. That means maybe the same information we collected twice in the data set. If you see inclusion exclusion criteria, we can have it to one patient for multiple records. So that you can able to get it here and you can see that day zero, what is the day zero before clinical trials or before giving that particular medication all the days we call it as a negative way that means those are all previous line. pre baseline, post baseline on baseline what is the difference between baseline and pre baseline? Baseline means before giving a drug to the patient, how the patient condition is going to be is a baseline., you just came to the hospital today, we collected and we take in all the information from you and this is the baseline. This is how your condition before giving a drug. That is all the. Before baseline, suppose tomorrow they will give you a drug to me, but today I just come because my health conditions and everything is right or not to cheque it just come to the hospital. That is going to be your previous line. Tomorrow when you come to the hospital and they are giving a medication to you, that is going to be baseline. So, all the persons are getting treated on the baseline. After taking that particular drug, how the patient is reacting is going to be post baseline. Previous line baseline and post baseline, so these are the technologies you need to keep in mind while working with this particular SAS programmer role. And this is the key things you need to keep in mind if somebody asked you what do you know about the protocol and study means. It’s a tidy title, a purpose primary object to secondary object tools, inclusion cafeteria’s, exclusion criteria and the assessment schedules.
