Documentation by CRC Bhushan Khemnar

[Virtual Presenter] We are going to go ahead with new studies soon. We have now experience of DCGI Presentation aims to know how CRC at any site should have documentation. Also it helps monitor to guide CRCs for doing documentation For any site, CRC is key person Dual responsibility for our CRCs: Conduct study activities as per protocol and guide Investigator Very basic. May be knowing to all. But we try to update ourselves with current experiences Ask as many as questions possible.

Importance of CRC Documentation FDA observations from recent inspection.

[Audio] Two end. One End Sponsor and other end is Investigator For Sponsor-Monitor is key person For Investigator- CRC is key person. Audits or inspection fails due to CRC responsibilities: Involvement in all activities (Identify new subjects, 2. Perform all screening activities, 3. Counsel patients 4. IP 5. Follow up) Complete failure of site can be due to CRC. Also, good data can be due to CRC only Example of Coimbatore site.

[Audio] Documentation helps to understand what and how activities were performed Example: Any exam: Examiner understand what preparation u have done through your written paper I have classified documentation at site level as per my understanding I don't want to give burden of any audit, guideline at start. First we need to learn how activities should be done. Than we would be able practically do those activities. Every section mentioned has its minimum requirements/importance At every time point CRC involvement is required. If CRC is not involved in the activities, he/she cannot complete any documentation. This basically leads to gap between documentation and activities performed.

[Audio] Is this a essential document? For AV may not be. To narrate what has happened in case of no av. Narrative started for this reason Incorrect narratives have laid to critical findings Nothing rocket science. No guideline says how narratives are written..

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Narration Real time Flow of activities Avoid template Maintain first time entry source.

Inform Consent Documentation (4/4). 02-12-2021. 8.

[Audio] Equally important document Investigator involvement is must CRC should guide investigator with template of I/E criteria, need of supportive documents For some criteria there is no source. In such cases investigator statement is required (Example: Life expectancy).

Eligibility Documentation (2/3). 02-12-2021. 10. [image].

INCLUSION CRITERIA 1. Age between 18 and 65 years (both inclusive) 2. Infection Criteria. Patient should have a known infection or a suspected infection, as evidenced by one or more Of the following: a. White cells in a normally sterile body fluid b. Perforated viscus [3 c. Radiographic evidence of pneumonia with purulent expectoration Yes No d. A condition associated with a high risk of bacterial infection (e.g. ascending cholangitis). e. Sepsis due to other infections (parasitic or viral infections) 3. Modified SIRS Criteria: (Patient has to meet two of the following four criteria): Ü a. A core temperature of? 382 C (100.42 F) orÉ 362 C (96.82 F) b. Heart rate of 2 90 beats/min, except in patients with a medical condition known to increase the heart rate or those receiving treatment that would prevent tachycardia c. Respiratory rate 2 20 breaths/min or PaC02 of 32 mm Hg orthe use of mechanical ventilation for acute respiratory' distress d. A white cell count of 212,000/mm3 or 4,000/mm3 or a differential count showing > 10 percent immature neutrophils. 4. Criteria for Severe sepsis: (Patient has to meet at least one of the following 9 criteria) a. Systolic blood pressure 90 mm Hg or mean arterial pressure s 70 mm Hg orthe use of vasopressors (Dopamine, epinephrine or norepinephrine) b. Urine output < ml/kg/hour for more than 2 hours despite adequate fluid resuscitation c. Creatinine > 2 mg/dL d. Acute lung injury with Pa02 to Fi02 250 in the absence of pneumonia as infection source e. Acute lung injury with Pa02 to Fi02 200 in the absence of pneumonia as infection source [3 f. Lactate level above upper limit of the normal value for the reporting laboratory. g. Total bilirubin 2 2 mg/dL h. Platelet count < 100,000/mm3 i. Coagulopathy (International Normalized ratio (INR) > 1.5).

[Audio] Maximum findings. Allocation (IWRS/Randomization) PI authorization/order for administration of allocated IP IP number/name Route Dosage Duration PI order for stop of IP.

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[Audio] IP related logs: Direct entry to logs Temperature: Record temperature what actually is Check the mode of refrigerator Reset Thermohygrometer.

Visit details Examination details Medication details (IP and conmed) AE Next visit.

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[Audio] Brand name written by PI. CRC googles it and mentions generic name. Is CRC pharmacist.

Adverse Event PI/Sub I documentation of AE (prescription) Details about complaints Start date Current status/End date Action taken Followed till closure.

Real time documentation No overwriting Sign and date on corrections Do not hide errors Involvement in all activities Coordination with PI Coordination with Monitor.

Thank You. 02-12-2021. 20.