Drug Inventory Log

Study Title: A Prospective, Open-label, Non-comparative, Multi-centric Active PMS to evaluate efficacy and safety
of STOMAFIT ORAL LIQUID containing Liquor Bismuth Ammonium Citrate 2.5ml, Belladonna Dry Extract 9mg,
Thymol 0.15mg and Menthol 0.2 mg in Gastritis or Gastroesophageal Reflux Disease (GERD)
Protocol No. CLI/PMS/003/19
Site name Apollo Hospital Site No. 2
IRB #:
PI Dr. Shravan Kumar Bohra
Storage location Storage temperature 25-30 ºC
Study Drug Name STOMAFIT ORAL DRUG Dose Form : Tablets Strength and Units;
Received Dispensed Returned to
Sponsor/Destroyed

Date Shipment Kit no. Batch no. Expiration NO. Quantity Received Dispensed No. of Date Dispensed Balance Date No. of Comments
Shipment # Date of per by To (Subject Tablets Dispensed by (Initials) Forword/ Returned to Tablets
Received Bottl Bottle (initials) ID) Dispensed Balance Sponsor or Returned
es Destroyed by Subject
IPZ08 038613 B036414 01 Dec 24 5 70 tabs PHA
01 APR 23

01 APR 23 IPZ08 038680 B036414 01 Dec 24 5 70 tabs PHA

01 APR 23 IPZ08 031518 B036414 01 Dec 24 5 70 tabs PHA VIP 777 70 tabs 01 May 23 PHA 350/ 280 01 June 23 4 Unused

01 APR 23 IPZ08 048683 B036414 01 Dec 24 5 70 tabs PHA

01 APR 23 IPZ08 048687 B036414 01 Dec 24 5 70 tab PHA

01 APR 23 IPZ08 047088 B036414 01 Dec 24 5 70 tabs PHA NNK 190 70 tabs 05 May 23 PHA 350/280 05 June 23 10 Unused

01 APR 23 IPZ08 048701 B036414 01 Dec 24 5 70 tabs PHA

Principle investigator’s signature Date : ----/ ---/-----

Name of Pharmacist Sign Date: __/__/___

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 INVESTIGATINAL PRODUCT DRUG ACCOUNTIBILITY LOG – SUBJECT RECORD

PROTOCOL TITLE: A Prospective, Open-label, Non-comparative, Multi-centric Active PMS to evaluate efficacy and safety of STOMAFIT ORAL LIQUID
containing Liquor Bismuth Ammonium Citrate 2.5ml, Belladonna Dry Extract 9mg, Thymol 0.15mg and Menthol 0.2 mg in Gastritis or Gastroesophageal
Reflux Disease (GERD)

PROTOCOL NO.: CLI/PMS/003/19 PRINCIPAL INVESTIGATOR: DR. SHRAVAN KUMAR BOHRA

SITE NAME: APOLLO HOSPITAL SITE NUMBER.: 02 INVESTIGATIONAL PRODUCT: STOMAFIT ORAL DRUG

SUBJECT ID 777 SUBJECT INITIAL: VIP

DISPENSING AREA: PHARMACY

INVESTIGATIONAL PRODUCT DISPENSING TO SUBJECT INVESTIGATIONAL PRODUCT RETURN TO SITE

Date IP Kit no. Batch No. Expiry Dose No. of Balance IP Date IP No. of IP Received Verification
dispensed to Date of IP tablets Forword Dispensed returned tablets By by CRA
Subject dispensed / Balance By from returned (Initials) (Initial and
to subject (Initials) Subject by Date)
Subject
01 May 23 031518 B036414 01 Dec 24 50 mg 70 350/280 Pharmacist 01 June 23 4 Pharmacist

Principle Investigator Name - DR. SHRAVAN KUMAR BOHRA SIGN DATE: __/__/___

NAME OF PHARMACIST SIGN DATE: ----/----/----

NAME OF CRA : SIGN DATE : __/__/__

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Version Date: Page 2
 INVESTIGATINAL PRODUCT DRUG ACCOUNTIBILITY LOG – SUBJECT RECORD

PROTOCOL TITLE: A Prospective, Open-label, Non-comparative, Multi-centric Active PMS to evaluate efficacy and safety of STOMAFIT ORAL LIQUID
containing Liquor Bismuth Ammonium Citrate 2.5ml, Belladonna Dry Extract 9mg, Thymol 0.15mg and Menthol 0.2 mg in Gastritis or Gastroesophageal
Reflux Disease (GERD)

PROTOCOL NO.: CLI/PMS/003/19 PRINCIPAL INVESTIGATOR: DR. SHRAVAN KUMAR BOHRA

SITE NAME: APOLLO HOSPITAL SITE NUMBER.: 02 INVESTIGATIONAL PRODUCT: STOMAFIT ORAL DRUG

SUBJECT ID 190 SUBJECT INITIAL: NNK

INVESTIGATIONAL PRODUCT DISPENSING TO SUBJECT INVESTIGATIONAL PRODUCT RETURN TO SITE

Date IP Kit no. Batch No. Expiry Date Dose No. of IP Balance Date IP No. of IP Received Verificati
dispensed to of IP tablets Dispensed Forword returned tablets By on by
Subject dispensed By / Balance from trial returne (Initials) CRA
(Initials) subject d by (Initial
subject and Date)
047088 B036414 01 Dec 24 50 mg 70 Tabs Pharmacist 350/ 280 05 June 23 10 Pharmacist
05 MAY 23

Principle Investigator Name - DR. SHRAVAN KUMAR BOHRA SIGNATURE DATE: __/__/__

NAME OF PHARMACIST SIGNATURE DATE: ----/----/----

NAME OF CRA SIGNATURE DATE: __/__/__

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 DRUG ACCOUNTIBILITY LOG FOR COMPALINCES

PROTOCOL TITLE: A Prospective, Open-label, Non-comparative, Multi-centric Active PMS to evaluate efficacy and safety of STOMAFIT ORAL LIQUID
containing Liquor Bismuth Ammonium Citrate 2.5ml, Belladonna Dry Extract 9mg, Thymol 0.15mg and Menthol 0.2 mg in Gastritis or Gastroesophageal
Reflux Disease (GERD)
PROTOCOL NO.: CLI/PMS/003/19 PRINCIPAL INVESTIGATOR: DR. SHRAVAN KUMAR BOHRA
SITE NAME: APOLLO SITE NUMBER.: 02 INVESTIGATIONAL PRODUCT: STOMAFIT ORAL DRUG
HOSPITAL
SUBJECT ID 123 SUBJECT INITIAL: ABC
DISPENSING AREA: PHARMACY

Dispensed to Subject Returned by Subject Compliance

Estimated number
Tablets Dispensed

Actual number of
Expected Date of
Expiry Date Of IP

Expected date of
Tablets Retuned
Date Dispensed

of tablets to be

% Compliance*
Date Returned

(Staff initials)
Dispensed by
(staff initials)
Kit Number

used/taken

used/taken
Verified by
Number of

Number of
First Dose

Last Dose

tablets
048687 01 Dec 24 70 01 May 23 Pharmacist 01 May 23 31 01 June 23 01 June 23 Pharmacist 39 62 63%

*
Calculation of % Compliance = Actual taken / Estimated to be taken X 100

Principle Investigator Name and Sign Date: ___/___/___

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