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Centr

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on: 02-Sept

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ENDICES ...

pendix A:

pendix B:

pendix C:

pendix D:

pendix E:

pendix F:

pendix G:

tember-2016

zation Syste

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Pharmacy

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Versi

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Dr. D

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tember-2016

meets one oatients 18 – atients 18 – atients > 60

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glutamine s

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survive the ned doctor in criteria.

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PENDICE

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21

Version: 24 August 2016 Reference: ICH GCP 4.1.5 and 8.3.24

Pharmacy Delegation & Training Log

The participating site pharmacy at ___________________________________________________________ has established a Standard Operating Procedure for the RE-ENERGIZE Study.

(site name) Pharmacy personnel listed in this log have been trained according to the Standard Operating Procedures. Name of Pharmacy contact*: __________________________________________ Signature of Pharmacy Contact: _________________________________________ *Pharmacy contact: is the main pharmacist/pharmacy technician that has been trained by the Methods Centre to carry out all pharmacy tasks related to the RE-ENERGIZE Study at the site.

Print Name

Signature

Initials Study Role

(Pharmacist, Technician,

etc)

Key

Delegated Tasks

(see above)

Training

Date of training

Trained by: Trainer, Webinar,

Self-Study, other - specify (if Trainer - provide name)

This log (or a similar log) is used by the Pharmacist at each site to: 1) Indicate the pharmacy staff that have been delegated duties/tasks related to The RE-

ENERGIZE Study and 2) Ensure that all pharmacy staff that have a material effect on The RE-ENERGIZE Study

have been trained on the study procedures. This log (or similar log) is to be kept by the Pharmacy and sent to the Sponsor upon request.

Key Delegated Tasks 1. Checking the treatment assignment on the Central Randomization System 2. Preparation and checking of Investigational Product 3. Labeling of Investigational Product 4. Maintaining Dispensing Logs 5. Maintaining Investigational Product Accountability & Destruction Records 6. Maintaining and managing inventory 7. Requesting resupply of inventory 8. Other (specify): ___________________________________________________

24 August 2016

Pharmacy Central Randomization System access Log

INSTITUTION: SITE NUMBER: INVESTIGATOR: Please complete the Central Randomization System (CRS) Access Log for the primary study Pharmacists/delegates at your site. A signature and email address is required to create a user account for the web based system for the RE-ENERGIZE Study.

DATE

NAME

TITLE

SIGNATURE

EMAIL

CERU Use Only

CR

S A

cces

s G

rant

ed

CR

S A

cces

s R

evok

ed

___ ___

___ ___

___ ___

___ ___

NOTE: By completing the information in the table above, the individual confirms they will have oversight responsibility for checking the randomization and dispensing/verifying study supplements for the RE-ENERGIZE Study. Pharmacy User ID and Password may be shared amongst all pharmacy staff using the CRS or each delegate may request her/his own accesss. Please complete and send to the Project Leader: Maureen Dansereau email: danserem@kgh.kari.net or fax: 613-548-2428

MALTRIN® M100 Maltodextrin

DESCRIPTION

MALTRIN® maltodextrins are bland, minimally sweet white carbohydrate powders produced from corn of U.S. origin. They are products with varying length polymer profiles that provide a wide range of viscosity and solubility characteristics. REGULATORY

MALTRIN® maltodextrins are generally recognized as safe (GRAS) as direct food ingredients at levels consistent with good manufacturing practices (21 CFR 184.1444). The correct labeling is “maltodextrin”, but all label declarations should be reviewed with appropriate legal counsel. PACKAGING, STORAGE AND SHELF LIFE

• Packaged in: 50-pound net, multiwall paper bags that are individually shrink wrapped; 2,000-pound tote bags; 25-kilogram bags.

• Store under ambient conditions; protect from excessive heat and excessive humidity for extended periods of time.

• Under good storage conditions the shelf life should be a minimum of two years. • MALTRIN® maltodextrins will remain stable, but may pick up moisture if stored in excessive

humidity, so reevaluation for moisture is recommended after one year to confirm the product still meets desired specifications.

PRODUCT ATTRIBUTES

• Heated solutions at 30% solids remain clear • Minimal contribution to viscosity at solids below 30% • Very low hygroscopicity • Low sweetness APPLICATIONS

• Source of energy for nutritional products • Aids in spray drying flavors or other ingredients • Carrier and dispersant for dry-blend mixes and seasonings • Prevents sugar crystallization in confections, frostings and glazes • Contributes to total solids in frozen desserts LOT CODES

Lot codes can be interpreted as follows: The first alpha character represents the product, followed by the last two numbers of the year and then the Julian date. Numbers following the Julian date represent the product line and the lot of the day. Example: M1310801: M = MALTRIN®; 13 = 2013; 108 = Apr. 18; 01 = first lot

Grain Processing Corporation

1600 Oregon Street | Muscatine, Iowa 52761 USA p: 563.264.4265 | f: 563.264.4289 e: food.sales@grainprocessing.com | grainprocessing.com

MALTRIN® and MALTRIN QD® are registered trademarks of Grain Processing Corporation. The information presented in this document is believed to be correct. Any recommendations or suggestions are made without guarantee or representation as to results for any particular usage. You are responsible for determining that the use of any GPC product, as well as your product and its use, and any claims made about your product, all comply with applicable laws and regulations for your particular jurisdiction. The information contained in this document is offered solely for your independent investigation, verification and consideration. © 2014 Grain Processing Corporation

STANDARD SPECIFICATIONS*

• Dextrose Equivalent 9.0-12.0

• Moisture, % 6.0 max.

• Ash (sulfated), % 0.5 max.

• pH (20% solution) 4.0-4.7

• Bulk Density (packed), lb/cu ft 30.0-39.0

• Aerobic Plate Count, CFU/g 100 max.

• Yeast/Mold, CFU/g 100 max.

• E. coli Negative/10 g

• Salmonella Negative/25 g * Any specification different from or not listed above must be agreed upon between the

customer and Grain Processing during specification approval.

CARBOHYDRATE LABELING INFORMATION**

• DP1 (glucose) grams per 100 grams 1

• DP2 (maltose) grams per 100 grams 3 ** Carbohydrate information reported “as is”.

DEGREE OF POLYMERIZATION (DP PROFILE)***

• DP1-7, % 30

• DP8-25, % 35

• DP26-40, % 1

• Greater than DP40, % 34 *** DP profile data reported “as is”.

M100 TI 011314

MALTRIN® M100 Maltodextrin

TYPICAL NUTRITIONAL INFORMATION

Values per 100 grams of product

Calories 378

Calories from Fat 0 g

Total Fat 0 g

Saturated Fat 0 g

Trans Fat 0 g

Monounsaturated Fat 0 g

Polyunsaturated Fat 0 g

Protein 0 g

Total Carbohydrate 94.5 g

Sugars 4 g

Dietary Fiber 0 g

Soluble Fiber 0 g

Insoluble Fiber 0 g

Sugar Alcohols 0 g

Other Carbohydrates 90.5 g

Calcium 16 mg

Iron 0 mg

Sodium 90 mg

Magnesium 6 mg

Potassium 5 mg

Phosphorus 8 mg Mandatory Nutrition Facts listed in bold

The above information is considered to be typical and not part of the product specification. Each value represents the average analyses performed using samples from several product lots. All nutrient data is reported for 100 grams of "as is" product, assuming 5 percent moisture and 94.5 grams of carbohydrate.

NOT a significant source of Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin K, Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Panthothenic Acid, Biotin, or minerals Chromium, Copper, Iodine, Manganese, Molybdenum, Selenium, Zinc.

29 January 2016

Site: ______________________________________________ Page _____ of ______

Patient ID#:_______________________ Patient Initials:____________Randomization #:______________________

1. Prescription date: ____________________ Dosing Weight: __________ Total Daily Dose: _________ grams

Did the prescription change ? 2. Prescription date: ____________________ Dosing Weight: __________ Total Daily Dose: _________ grams

3. Prescription date: ____________________ Dosing Weight: __________ Total Daily Dose: _________ grams

Date Glutamine Maltodextrin Initials Total Daily

Dose (g)

Quantity Dispensed

(# 5g packets)

Lot & Expiry Total Daily Dose (g)

Quantity Dispensed

(# 5g packets)

Lot & Expiry

Pre

pare

d By

Che

cked

B

y

Investigational Product Dispensing Log - Patient Treatment Allocation: Glutamine Maltodextrin (placebo)

Yes No

09 October 2016

Site: _______________________________________________________ Page ____ of ____

The Investigational Product Accountability Log should be completed by the Pharmacist/delegate

Date Quantity Lot # Expiry Date Quantity Dispensed

Patient Randomization

#

Balance of Product

Signature Received Destroyed

Investigational Product Accountability Log Glutamine

09 October 2016

Site: _______________________________________________________ Page ____ of ____

The Investigational Product Accountability Log should be completed by the Pharmacist/delegate

Date Quantity Lot # Expiry Date Quantity Dispensed

Patient Randomization

#

Balance of Product

Signature Received Destroyed

Investigational Product Accountability Log Maltodextrin