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投稿
Sankt-Petersburg’da bir klinik araştırmalar şirketinde kalite denetçi olarak çalışıyorum.
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Have you ever had an idea that possess you utterly? It looks like I have such one now. How do I knew it? It is easy – I cannot fall asleep until 4-5 a.m. and I am constantly thinking about this crazy thing. I think about moving from St.Pete to Istanbul (by the way, have you known that they are sister-cities?).
If you had asked me about the places I would like to live a month ago, I would have named Edinburgh, Oban, Inverness or any other city/town/village in Scotland. But everything changed a week ago, when I returned from my second visit to Istanbul during a month. It happened due to all these pandemic restrictions and uncertainty - I decided to go to Turkey in October for a week holiday by my own, and two weeks later I met there my sister, who lives in Ireland.
My first visit to Istanbul was terrible. While going from the New international airport to my hotel in Fatih district, I realised how huge it was. Shame on me, but I had no idea about its population and size (frankly speaking, I went there to see what’s left of Constantinople, I even had with me a thick book titled “Searching for Constantinopol”). That time, my depression lasted for three days!!!! And only on the last day in the city, I started to feel it.
To be continued...
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Lección dos. Ser/Estar
Yo soy Liudmila. Soy rusa. Soy de Sankt Petersburgo. Soy auditora en las investigaciones clínicas. Soy delgada, no soy alta.
No soy casada, soy soltera.
Estoy en casa. Mi casa es bonita.
Estoy contenta. No estoy enferma.
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What is your favorite dish/recipe?
I've got a task to prepare a dish that is popular in an English-speaking country. But to my shame, I recalled fish&chips, black pudding, and haggis only (because I've been only in Scotland :)).
I will be very grateful if you share with me names of your favorite dishes (with the recipes or without) or give me some ideas.
By the way, if you are interesting in Russian cuisine, we can discuss it too.
So, let us tell about food and cuisine :)
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Article question.
There are no articles in Russian, so it is a nightmare for me to understand where they should be used and where not. Yesterday I read that when we are talking about the things, which is obvious for both communicating parties, article “the” can be omitted. The example they provided was the following: you arrived to an airport and speak with another person there. The article is unnecessary in this case. Could you please confirm or deny it?
Thank you very much to all!
PS. By the way, is it polite or at least ok, if you read “thanks a lot in advance” in business (semi-formal) emails?
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Discovery of olive oil
Many people know about grape varieties as well as the fact that the wine could be made from one kind of grape or from several ones.
Well, today I've learnt that the same classification applies to olive oil too. It happened in a huge shop with a myriad of glass bottles and cans filled with different types of oils from pale yellow (with white sediment in unpurified oil) to dark green. A shop assistant recommended me to take the oil produced from the prime variety "Koroneiki" at Crete. She said that this is the softest olive oil without bitter taste. And she was right - the oil turned out to be a perfect one!
So, one more interesting shop has appeared in the city, and I am at the beginning of a long way to get familiar with the world of olive oil.
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Opening meeting_part 1
This is how I see the opening meeting I should run tomorrow. This will be the first one in English and I will be grateful for corrections and comments!
Dear Prof….., dear team, good morning to everyone again,
As you already know, we represent the Quality Management department of (name) company and today and tomorrow, we are going to conduct an internal audit of the site within the (name) study. “Internal” means that we will not report the audit´s results to the sponsor unless there are any serious or critical observations.
For these two days, we are going to review the patients’ files, including the signed ICFs and completed SAE report forms, and verify data for several patients in the electronic database.
We also plan to check the onsite study file and visit the facilities involved in the study: the local laboratory, study medication storage area, rooms where you examine and treat the study subjects, area for biosamples collection and processing and the area where you keep the study documents and supplies.
These are all activities we plan to do and we are flexible for their scheduling, so we could have the facility tour and visit the local laboratory when it is convenient for you, your team and other staff.
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Opening meeting_continuation
Usually, we start working with the source records and the site archive, but before that, we would like to ask you some questions regarding this study.
1) The study is rather specific; however, you enrolled 10 patients and where did they come from – ware they the patients who received treatment in this hospital, or maybe you have any referral system and some patients came from other medical institutes?
2) Did you face any problem during the study?
a. In consenting patients (did any patients refuse to participate in the study?)
b. Or related to the central laboratory (courier services, receiving lab reports)
c. Any problem with eCRF or IWRS
d. Study drug delivery
e. With our company (site monitor, medical monitor) – we check our side too
3) Could you please tell us about your team and delegation of responsibilities between the team members? In other words, how does it work at your site -
a. Who selects the patients and obtains inform consent,
b. Who performs study-specific procedures
c. Who maintains the source records
d. Who works with IWRS
e. Who completes eCRF
f. Who is responsible for the study drug:
i. Receipt
ii. Storage and accountability
iii. Dispensation
iv. Administration
g. Who maintained temperature logs
h. Who is responsible for communication with the Ethics Committee?
4) And a couple of words about your experience in clinical trials
a. How long have you worked as a principal investigator?
b. How many studies are you running now?
c. How many studies have you conducted, and what indications were they?
d. Have you had any regulatory inspections (FDA, EMA, local (Germany) RA)?
Thank you very much for your answers. It looks like we asked everything we need for now, and now we will be happy to listen to your comments regarding this study and your experience with our company.
…..
The last question is about Internet connection – can we use the local Wi-Fi?))
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New Year promises))
As usual, the new year came with some promises. Like it has been for many previous years... But this time I am going to change my strategy to get different results.
What am I going to do?
First of all, I am planning to study English regularly. My goal is B2-C1 by the middle of the year. (I have something like B1+/B2- now). And I will report my progress here at least every other day.
The second one is my Spanish classes. I have started studying Spanish last year, and I need B1 before the end of 2020. The reason for this deadline is a trip to South America I am going to do in 2021. And I promised to go there being available to speak Spanish (During my three previous trips I spoke only English). I am going to complete the online course I have started and to take one more course in summer. If I do not meet A2 in August 2020, my trip will be postponed till 2022.
And the third one is to complete the basic program in the online photography school, which I started three(!) years ago (shame on me!!). I will try to report monthly about my progress here.
If I fail, I will erase my photo archive for 10 years! It would be awful((((
Does anyone have a working strategy to keep New Year promises?
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St.Petersburg call number
I have 10 minutes to write something here.
So, I would like to share a good news with you - St.Petersburg has its own call namber now. You may call at +78129301703 and will be connected with any of "Petersgurger" (I am not sure this word is correct) registered in the system. According to statistics, 6500 russians and 1150 people form other countries (21) have used this servece and talked for 10 days and 15 hours since the 29th of June 2016.
I think it is a very goor idea, is not it?
2016年7月2日
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