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How do I register a study on clinical trials government?

How do I register a study on clinical trials government?

Steps for Registering a Clinical Study

  1. Determine who is responsible for registering the clinical study and which Protocol Registration and Results System (PRS) account should be used.
  2. Learn about submission requirements.
  3. Login to PRS.
  4. Enter the required and optional data elements.

What studies must be registered on ClinicalTrials gov?

ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to:

  • Any applicable human subject or ethics review regulations (or equivalent)
  • Any applicable regulations of the national or regional health authority (or equivalent)

What else must be on the label of all stock solutions?

Labels on purchased chemicals must include: The common name of the chemical. The name, address and emergency phone number of the company responsible for the product. An appropriate hazard warning.

What is the minimum information required for a manufacturer’s label?

All labels are required to have pictograms, a signal word, hazard and precautionary statements, the product identifier, and supplier identification. A sample revised HCS label, identifying the required label elements, is shown on the right. Supplemental information can also be provided on the label as needed.

What three things should always be included when labeling samples?

The label must contain the following legible information:

  • Patient name.
  • Patient medical record number, with check digit.
  • Patient location.
  • Collection date and time.
  • Specimen type and/or source.
  • Test required (note any special handling required)
  • Ordering physician.

What are the five things that must go on your specimens when labeling?

Each package should contain a line list with the following information for each included specimen: patient name, ID number, date collected, specimen type, clinical contact name and phone number, and submitter contact name, affiliation, phone number and e-mail address.

What is the best thing to do with an unidentified specimen?

Unlabeled or unidentified specimens will NOT be processed until properly labeled by physician or their designee. The specimen must be accompanied by a Surgical Pathology Order. Completion of ALL essential information will optimize tissue interpretation and patient care.

What are the consequences of not labeling specimens correctly?

Unquestionably, the most serious consequence of specimen labeling errors on the direct care of patients is of one of the following types: Failure to provide proper and immediate care to a patient based on the lack of accurate test results associated with the proper patient.

What are three specimen collection methods?

Three popular methods of blood collection are:

  • Arterial Sampling.
  • Venipuncture Sampling.
  • Fingerstick Sampling.

Can you describe any examples of negative consequences of incorrectly Labelling a specimen?

Increased staff hours and length of patient stay are also costly consequences associated with specimen labeling errors. The threats specimen labeling errors have on your laboratory surpass monetary increases, and hinder the efficiency of your lab. Valuable staff time is wasted by performing label error corrections.

What are the reasons for specimen rejection?

The most common reasons for specimen rejection were contamination (n=764, 35.1%), inappropriate collection container/tube (n=330, 15.2%), quantity not sufficient (QNS) (n=329, 15.1%), labeling errors (n=321, 14.7%), hemolyzed specimen (n=205, 9.4%), and clotted specimen (n=203, 9.3%).

What is sample rejection?

Sometimes tests cannot be performed in the laboratory if samples fall short of the quality, volume or other eligibility criteria. In these cases, the laboratory may need to reject the samples, and not carry out processing.

What are criteria for blood sample rejection?

Examples of sample rejection criteria

  • Unlabelled or mislabelled samples.
  • Duplicate samples. Most duplicate samples received on the same day are unacceptable and should not be processed.
  • Leaky containers.
  • Contaminated samples.
  • Inappropriate sample sources.
  • Delayed transport time and sample processing.

What are the criteria for rejecting cytology sample?

SPECIMENS WILL BE REJECTED IF: 1. The container and/or slides are not properly labeled with the patient’s name and ID number. 2. The requisition contains incomplete patient information.

What is Hemolyzed sample?

Abstract. The term hemolysis designates the pathological process of breakdown of red blood cells in blood, which is typically accompanied by varying degrees of red tinge in serum or plasma once the whole blood specimen has been centrifuged.

Why would a lab reject a urine sample?

Routine Microbiology The most common reasons to reject a specimen are due to the addition of a preservative (such as formalin or alcohol).

Which is correct for histology specimen rejection criteria?

Histology specimens are considered to be unrepeatable or unique specimens as in a number of circumstances, it is not possible to repeat the collection of the sample. All attempts to correct the unacceptability of the specimen are exhausted before any specimen can be rejected.

What is the most common cause of specimen rejection in laboratories?

Sample rejection ratios (SRRs) according to test groups. The most common rejection causes according to the test groups were the presence of fibrin clots (28%) and insufficient volume (9%) were the most frequent causes of rejection of biochemical tests.

Why is Hemolyzed sample not accepted?

Serum/plasma samples submitted for potassium measurement are quite frequently rejected for analysis because they show the telltale signal of hemolysis, i.e. a reddish discoloration due to the presence of hemoglobin.

What are the criteria for rejection of gross specimen for histopathology studies?

​Rejection

  • Incorrect specimen collection container.
  • insufficient specimen quantity.
  • Transported incorrectly.
  • Inadequate fixative.
  • specimen too large for container.
  • Incorrect media.
  • Specimen stability compromised (i.e. age of specimen, temperature stored)

When a sample is rejected for QNS what is the appropriate response?

Phlebotomy

Question Answer
Which of the following is not a primary method of venipuncture? Lancet.
Why is blood drawn in a specific order? To avoid cross-contamination of additives.
When a sample is rejected for QNS, what is the appropriate response? Collect another sample with sufficient quantity.

What are the different criteria for rejection of specimens submitted in the microbiology section?

​Rejection Criteria of Clinical Microbiology Specimens

  • Duplicate specimen collected within 5 days.
  • Improper specimen received.
  • Insufficient quantity for analysis.
  • Plasma NOT separated from whole blood within 24 hours.
  • Specimen received greater than 24 hours from time of collection.

How do you prepare a patient for blood collection?

Infection prevention and control practices.

  1. Assemble equipment.
  2. Identify and prepare the patient.
  3. Select the site.
  4. Perform hand hygiene and put on gloves.
  5. Disinfect the entry site.
  6. Take blood.
  7. Fill the laboratory sample tubes.
  8. Draw samples in the correct order.

What must be avoided when collecting a stool specimen?

If possible, avoid the following within 48 hours before stool collection: Pepto Bismol, Maalox, mineral oil, antacids (Rolaids, Tums), Kaopectate.

What type of stool specimen must be sent to the laboratory immediately?

A stool specimen for the presence of ova or parasites must be taken to the laboratory immediately. What is the probable source of bright red blood in the stool?

How long can you keep a stool sample?

Storing a stool sample If you can’t hand the stool sample in immediately you should store it in a fridge (but for no longer than 24 hours). Place the container in a sealed plastic bag first.

When should you do a stool test?

The test is usually ordered if you’re experiencing symptoms associated with an intestinal infection like:

  1. Presence of blood or mucus in your stool.
  2. Frequent diarrhoea.
  3. Fever.
  4. Acute abdominal pain.
  5. Headache.
  6. Vomiting or nausea.

What is normal stool report?

Results

Normal: The stool appears brown, soft, and well-formed in consistency.
The stool does not contain blood, mucus, pus, undigested meat fibres, harmful bacteria, viruses, fungi, or parasites.
The stool is shaped like a tube.
The pH of the stool is 7.0–7.5. footnote 1
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