Question

Clinical trial

The design of the clinical trial for this study represented a single centered, double blind, placebo-controlled trial that utilized randomization to target patients for the trial. The eligible patients for the study were aged 21-90 years and after receiving a biopsy, these patients had confirmed colorectal adenocarcinoma and were deemed eligible for receiving treatment for the surgery to remove their adenocarcinoma, but were instead given an opportunity to participate in this research trial with written informed consent. Potential research participants were excluded from participating in the study if they experienced hypersensitivity to artesunate, were pregnant, experienced a history of hearing and balance problems, or experienced immunosuppression or other medication that would negatively interact with the drug (artesunate). Other exclusions included the failure or inability to give informed consent, women who were of child-bearing age refusing to take contraception, and any patient suffering from chronic kidney disease that was at stage 3 or above.

The patients in the double blind study would either receive two weeks of the medication or a placebo prior to receiving surgery and standard care with the intent to ascertain whether those who received artesunate had their tumors shrink or be impacted by taking this drug. Those who received artesunate instead of the placebo took 200 mg orally of artesunate daily for fourteen days. Each patient who received artesunate as well as those who received the placebo would be required to stop the medication within 72 hours of their surgery. The 62 day rule that requires patients to receive treatment within this time frame after a confirmation of the diagnosis for colorectal cancer was adhered to by researchers for the clinical trial.

Patient Demographic Data Discrepancies

a. if the date of birth of the patient is incorrect.

b. If the gender of the patient is incorrect.

Range checks Discrepancies

a.  if the patient is pregnant.

b. If the Biopsy result of the patient confirmed to be negative

Consistency checksDiscrepancies

a. Date of birth to the reported age (21-90 year). If patient recruited under 21 or about 90 is a discrepancy.

b. Informed consent received or not. If not receive it’s a discrepancy

c. Suffering from colorectal cancer or not. I the patient is not suffering from colorectal cancer it’s a discrepancy

Protocol violationDiscrepancies

a. Surgery not to be done before 72 hrs after stopping medication. If  performed is a protocol violation.

b. Medication of the amount 200 mg should be taken daily for 14 days. If not adhered is a protocol violation.

Questions

For each the data discrepancies you identified above,

1

Describe in detail how you would go about retrieving the data? (If you use a written mode, make sure you provide the actual query in your response). Give samples of documentation that you would use.

2

. For each of the 4 types of discrepancies discussed above, if the data cannot be retrieved, what would you do? (3-4 paragraphs)

No plagiarism no bullet points please