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unit 4 assingment 4

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Report on Data Storage and Transfer: (1500 maximum) Identify who will need to access volunteer records and describe why. Identify who will need to access trial records and describe why. Identify who will need to access the records about the chemical structure of each drug and describe why. Identify who will need to access records about raw materials and describe why. For a paper-based record system: For research: Describe how the volunteer records are initially created by the company and updated with information from their GP surgery. Describe the process involved in storing and updating volunteer records with clinical trial information. Identify processes involved in accessing and updating volunteer records to ensure traceability. Describe the process for the research and development department to access information from trial records. Identify problems in the research and development department analyzing and presenting data from trial records to other companies. Explain procedures in place to ensure the company follows GDPR guidance For manufacturing: Describe the processes in place to ensure stock levels are controlled, from when the stock arrives to when the product leaves. Describe how changes to the design of a product might be communicated to the production department and the effect on other departments. Identify the processes involved in accessing and using stock to ensure traceability. Repeat the previous steps for a system using a cloud-based LIMS system: Compare the advantages and disadvantages of each system: Justify the use one system:

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Useful scientific information is stored and retrieved using science and computer which is
called informatics you have a scientific information which is a lot of information, so you
store or put away thins information into a database. Informatics processes the data for the
storage and retrieval and gives particular information that you are looking for. Informatics is
stored in large databases and it used mostly in particular field in science such as human
genome project and all the particular field inside it like DNA and RNA, sequencing of amino
acid and a whole lot of different things. It is also major player in health records, and you
need any hospital admins to store the paper records but you need coder to store
information but there is a disadvantage of the hospital getting hacked and losing the data. It
is beneficial because in these fields huge amount of data is stored and retrieved at a later
date.

Records that are kept in organizations depending on what company you are working for you
may have a set of rules on how you record the laboratory work. Any samples of chemicals
should be registered in when they are brought into the lab. Some substances are managed
with specific equipment so you must go along with the rules. You have to keep evidence of
all the chemicals substances that are stored in the lab and when they are taken out of the
storage because they are being used. You should keep a file or a record of where all the
chemical is. When a chemical-substances arrives in the lab it must be tagged following the
rules of COSHH. It must be recorded where the chemical substances came from if there are
any problems with the sample you must trace where it came from. Every single sample has
an identification number this is when the time of the sample was booked in, the date of the
sample and has a unique number at the end. A note should be taken of the number when
the sample is being used this enables the traceability of the sample. The type of data
collected is health and safety checks this make sure that it is being controlled and to write
report about accidents and what you can you do to reduce the number of accidents taking
place. The equipment’s used in the organization Another type of data collected is COSSH,
quality assurance, and the samples.

Recording, processing, storing, and extracting the useful information can meet the customer
needs because the customers knows that everything, they do have traceability this is the
way to ensure traceability this is the ability to track information about all the key part in the
materials to ensure what comes into your organization and what leaves you organization
bar coding all the dangerous stuff to know that your workers know it and also how to handle
it.

Identify who will need to access voluntary data record and describe why?

The accessing records are under strict rules about sharing to a third party for example in
clinical trial the only people that can see is the voluntary records is the people that
participated in creating the clinical trial and also help with the development of the clinical
trial. Also, the nurse they give you the injection and also give you the care you need and also
call in for appointments to check any side effects. The clinic administrator also plays a big
role this depends if you want to do an automated system these are the coders who store
this information or also if you want a fully automated system like LIMS that tell you. On the
other hand, the admin staff can store the information into the filing cabinet. There are strict

, rules you have to follow such as GDPR that restrict you from sharing this personal
information to third party.

Identify who will need to access the records about the chemical structure of each drug and
describe why?

Laboratory technicians and the research assistants will need to access records about the
chemical structure of the drug this is because for the research to develop. The chemical
structure of the drug control the properties of the drug and even the function of the drug. A
chemist will also need to access records about the chemical structure of the drug to modify
the structure if there are major side effects. For this to happen they also need to check their
patients’ medical history to show if the drug is suitable for them. The manufacturing team
will also need the chemical structure of the drug and they will need to label the drug
according to the guidance of HSE so the types of rules they need to follow is COSHH labelling
any allergies so that the person knows if that type of drug is suitable for them.

The raw materials used in the pharmaceutical laboratory are checked by a few departments.
The research assistants and the laboratory technicians need to access the records because
they are the ones that are developing the drug. Also, the research assistants and the
laboratory technicians should access this record and their research development manager
should double check because accuracy is needed for the raw materials so he/she will also
need access to this data. The packaging is the plastic, glass and aluminium foil the
warehouse operative and the manufacturing operatives and also their manager should
access this data.


Describe how volunteer records are initially created by the company and updated with the
information from the GP surgery.


The records from the volunteer are created when they come in for the trial this information
is the confidential information about the patient’s medical history and the doses are you
giving them for the drugs. All this information is taken not and stored by paper. The results
will be copied into the laboratory notebook. After a few dozen of people have done it
depending on the volume of how big or small the clinical trial is they can create a report on
the finished research. Unless there are urgent results that need to be communicated with a
hospital or even if the GP is doing a routine check on them for any side effects of that drug
the results will need to be sent to the GP or the hospital.


Describe the process involved in storing and updating volunteer records with clinical trial
information

The patients come to the laboratory for the clinical trial. A record is created they document
relevant information about the patients through this day. The patient then leaves, and they
send this information to the admin staff for the paper-based record system and they store it
in the storage facility. They then send this information to the GP and their local hospital to

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Subido en
12 de febrero de 2022
Número de páginas
7
Escrito en
2021/2022
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ENSAYO
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