DOCUMENT NUMBER SRD-0126767 STATUS Effective

VERSION 5.0 Effective Date 19-Oct-2021 

Global: Inventory and Dispensing Log Templates

Global: Inventory and Dispensing Log Templates

INVENTORY/DISPENSING LOG with Destruction

(Basic log: IMP administered on-site with destruction on-site, open-label)

Study No: Site No.: Investigator Name:

IMP Name: *Strength: *Batch No.:

IMP Dosage Form: Storage Conditions: **Storage Location:

Number of Verify Destruction

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

IMP Received IMP Dispensed Balance Containers/

Recorder Quantity Destroyed
***Comments:
Use By Date: Initials: Date
Date: Date: CRF # or Received- A C
Qty: Qty: (Expiry Date) Used: Unused: Destroyed: B Initials:
(DD-MMM-YYYY) (DD-MMM-YYYY) Subject ID: (DD-MMM-YYYY) Dispensed:
(DD-MMM-YYYY)

Overall completion date:(DD-MMM-YYYY) Complete name of Responsible:

This form may be signed using a CFR 21 Part 11 compliant electronic signature, such as DocuSign Part 11 (GxP Relevant) or other digital signature, where
SIGNATURE this is in accordance to local legal and regulatory requirements. In cases, where this form cannot be signed using a CFR 21 compliant signature, a
handwritten (wet-ink) signature may be used.
A
* Record one strength and one batch no. per page. Used includes IMP dispensed to subjects, dispensed but not opened, or assigned but never
** If applicable (i.e. Refrigerator No., Shelf No., dispensed.
KEY Thermometer No.) B
Date indicates the date that the medication was placed in the appropriate a waste container for
*** Document IMP deviation number if applicable. the purpose of containment until destruction.
C
Initials of person discarding medication in appropriate container.
Archiving The signed original paper document (e.g., with handwritten [wet-ink] signature) must be retained and archived at the site of origin of the final document (i.e.,
Statement where the final signature was obtained) unless local regulatory requirements state otherwise. A copy is to be filed in the Roche TMF.

SRD-0126767 (V 5.0) Modifiable example Page ___ of ___

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

 DOCUMENT NUMBER SRD-0126767 STATUS Effective
VERSION 5.0 Effective Date 19-Oct-2021 
Global: Inventory and Dispensing Log Templates

Global: Inventory and Dispensing Log Templates

INVENTORY/DISPENSING LOG with Destruction

(Basic log: IMP administered on-site with destruction on-site, open-label)

Study No: Site No.: Investigator Name:

IMP Name: *Strength: *Batch No.:

IMP Dosage Form: Storage Conditions: **Storage Location:

Number of Verify Destruction

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

IMP Received IMP Dispensed Balance Containers/

Recorder Quantity Destroyed
***Comments:
Use By Date: Initials: Date
Date: Date: CRF # or Received- A C
Qty: Qty: (Expiry Date) Used: Unused: Destroyed: B Initials:
(DD-MMM-YYYY) (DD-MMM-YYYY) Subject ID: (DD-MMM-YYYY) Dispensed:
(DD-MMM-YYYY)

Overall completion date:(DD-MMM-YYYY) Complete name of Responsible:

This form may be signed using a CFR 21 Part 11 compliant electronic signature, such as DocuSign Part 11 (GxP Relevant) or other digital signature, where
SIGNATURE this is in accordance to local legal and regulatory requirements. In cases, where this form cannot be signed using a CFR 21 compliant signature, a
handwritten (wet-ink) signature may be used.
A
* Record one strength and one batch no. per page. Used includes IMP dispensed to subjects, dispensed but not opened, or assigned but never
** If applicable (i.e. Refrigerator No., Shelf No., dispensed.
KEY Thermometer No.) B
Date indicates the date that the medication was placed in the appropriate a waste container for
*** Document IMP deviation number if applicable. the purpose of containment until destruction.
C
Initials of person discarding medication in appropriate container.
Archiving The signed original paper document (e.g., with handwritten [wet-ink] signature) must be retained and archived at the site of origin of the final document (i.e.,
Statement where the final signature was obtained) unless local regulatory requirements state otherwise. A copy is to be filed in the Roche TMF.

SRD-0126767 (V 5.0) Modifiable example Page ___ of ___

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

 DOCUMENT NUMBER SRD-0126767 STATUS Effective
VERSION 5.0 Effective Date 19-Oct-2021 
Global: Inventory and Dispensing Log Templates

Global: Inventory and Dispensing Log Templates

INVENTORY/DISPENSING LOG with Destruction

(Basic log: IMP administered on-site with destruction on-site, open-label)

Study No: Site No.: Investigator Name:

IMP Name: *Strength: *Batch No.:

IMP Dosage Form: Storage Conditions: **Storage Location:

Number of Verify Destruction

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

IMP Received IMP Dispensed Balance Containers/

Recorder Quantity Destroyed
***Comments:
Use By Date: Initials: Date
Date: Date: CRF # or Received- A C
Qty: Qty: (Expiry Date) Used: Unused: Destroyed: B Initials:
(DD-MMM-YYYY) (DD-MMM-YYYY) Subject ID: (DD-MMM-YYYY) Dispensed:
(DD-MMM-YYYY)

Overall completion date:(DD-MMM-YYYY) Complete name of Responsible:

This form may be signed using a CFR 21 Part 11 compliant electronic signature, such as DocuSign Part 11 (GxP Relevant) or other digital signature, where
SIGNATURE this is in accordance to local legal and regulatory requirements. In cases, where this form cannot be signed using a CFR 21 compliant signature, a
handwritten (wet-ink) signature may be used.
A
* Record one strength and one batch no. per page. Used includes IMP dispensed to subjects, dispensed but not opened, or assigned but never
** If applicable (i.e. Refrigerator No., Shelf No., dispensed.
KEY Thermometer No.) B
Date indicates the date that the medication was placed in the appropriate a waste container for
*** Document IMP deviation number if applicable. the purpose of containment until destruction.
C
Initials of person discarding medication in appropriate container.
Archiving The signed original paper document (e.g., with handwritten [wet-ink] signature) must be retained and archived at the site of origin of the final document (i.e.,
Statement where the final signature was obtained) unless local regulatory requirements state otherwise. A copy is to be filed in the Roche TMF.

SRD-0126767 (V 5.0) Modifiable example Page ___ of ___

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

 DOCUMENT NUMBER SRD-0126767 STATUS Effective
VERSION 5.0 Effective Date 19-Oct-2021 
Global: Inventory and Dispensing Log Templates

Global: Inventory and Dispensing Log Templates

INVENTORY/DISPENSING LOG with Destruction

(Basic log: IMP administered on-site with destruction on-site, open-label)

Study No: Site No.: Investigator Name:

IMP Name: *Strength: *Batch No.:

IMP Dosage Form: Storage Conditions: **Storage Location:

Number of Verify Destruction

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

IMP Received IMP Dispensed Balance Containers/

Recorder Quantity Destroyed
***Comments:
Use By Date: Initials: Date
Date: Date: CRF # or Received- A C
Qty: Qty: (Expiry Date) Used: Unused: Destroyed: B Initials:
(DD-MMM-YYYY) (DD-MMM-YYYY) Subject ID: (DD-MMM-YYYY) Dispensed:
(DD-MMM-YYYY)

Overall completion date:(DD-MMM-YYYY) Complete name of Responsible:

This form may be signed using a CFR 21 Part 11 compliant electronic signature, such as DocuSign Part 11 (GxP Relevant) or other digital signature, where
SIGNATURE this is in accordance to local legal and regulatory requirements. In cases, where this form cannot be signed using a CFR 21 compliant signature, a
handwritten (wet-ink) signature may be used.
A
* Record one strength and one batch no. per page. Used includes IMP dispensed to subjects, dispensed but not opened, or assigned but never
** If applicable (i.e. Refrigerator No., Shelf No., dispensed.
KEY Thermometer No.) B
Date indicates the date that the medication was placed in the appropriate a waste container for
*** Document IMP deviation number if applicable. the purpose of containment until destruction.
C
Initials of person discarding medication in appropriate container.
Archiving The signed original paper document (e.g., with handwritten [wet-ink] signature) must be retained and archived at the site of origin of the final document (i.e.,
Statement where the final signature was obtained) unless local regulatory requirements state otherwise. A copy is to be filed in the Roche TMF.

SRD-0126767 (V 5.0) Modifiable example Page ___ of ___

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

 DOCUMENT NUMBER SRD-0126767 STATUS Effective
VERSION 5.0 Effective Date 19-Oct-2021 
Global: Inventory and Dispensing Log Templates

Global: Inventory and Dispensing Log Templates

INVENTORY/DISPENSING LOG with Destruction

(Basic log: IMP administered on-site with destruction on-site, open-label)

Study No: Site No.: Investigator Name:

IMP Name: *Strength: *Batch No.:

IMP Dosage Form: Storage Conditions: **Storage Location:

Number of Verify Destruction

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

IMP Received IMP Dispensed Balance Containers/

Recorder Quantity Destroyed
***Comments:
Use By Date: Initials: Date
Date: Date: CRF # or Received- A C
Qty: Qty: (Expiry Date) Used: Unused: Destroyed: B Initials:
(DD-MMM-YYYY) (DD-MMM-YYYY) Subject ID: (DD-MMM-YYYY) Dispensed:
(DD-MMM-YYYY)

Overall completion date:(DD-MMM-YYYY) Complete name of Responsible:

This form may be signed using a CFR 21 Part 11 compliant electronic signature, such as DocuSign Part 11 (GxP Relevant) or other digital signature, where
SIGNATURE this is in accordance to local legal and regulatory requirements. In cases, where this form cannot be signed using a CFR 21 compliant signature, a
handwritten (wet-ink) signature may be used.
A
* Record one strength and one batch no. per page. Used includes IMP dispensed to subjects, dispensed but not opened, or assigned but never
** If applicable (i.e. Refrigerator No., Shelf No., dispensed.
KEY Thermometer No.) B
Date indicates the date that the medication was placed in the appropriate a waste container for
*** Document IMP deviation number if applicable. the purpose of containment until destruction.
C
Initials of person discarding medication in appropriate container.
Archiving The signed original paper document (e.g., with handwritten [wet-ink] signature) must be retained and archived at the site of origin of the final document (i.e.,
Statement where the final signature was obtained) unless local regulatory requirements state otherwise. A copy is to be filed in the Roche TMF.

SRD-0126767 (V 5.0) Modifiable example Page ___ of ___

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

 DOCUMENT NUMBER SRD-0126767 STATUS Effective
VERSION 5.0 Effective Date 19-Oct-2021 
Global: Inventory and Dispensing Log Templates

Global: Inventory and Dispensing Log Templates

Inventory and Dispensing Log Principles

 The investigator, institution and/or a pharmacist or other appropriate individual, who is designated by the investigator and/or institution, maintains records of the product's
delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s). These records include
dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the IMP(s) and trial subjects. Investigators maintain
records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all IMP(s) received from the sponsor.
 Depending on the study design, product usage patterns or if the site has an external satellite site handling IMP (e.g., pharm acy, cyto-toxic or IV preparation,.) more than
one Accountability and Dispensing log may be needed to capture the full cycle of IMP management.
Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL

 IMP which meets the definition of “Bio-hazard” need to be handled in accordance with the relevant regulations including country requirements. These “bio -hazard” IMP
containers and packaging need to be placed in the appropriate waste containers at the time they are being prepared for dispensing to a subject. Study Inventory and
Dispensing records and any other site-specific pharmacy logs are used by monitors to check reconciliation and destruction records.
 Bio-hazard IMP needs to be destroyed at study site. Adequate procedures and use of appropriate logs to track drug through to destruction need to be in place at study site.
 Non-biohazard IMP which is to be destroyed at site needs to be properly documented in Inventory and Dispensing logs, and destruction needs to be documented in
appropriate certificate of destruction or Global: Onsite IMP Destruction Form (SRD-0135243) if applicable. Please refer to Global: Investigational Medicinal Product
Management (SOP-0104924).
 For blinded studies the MEDNO is used in place of a batch number.

Complete name of
Overall completion date: (DD-MMM-YYYY)
Responsible:

SRD-0126767 (V 5.0) Modifiable example Page ___ of ___

Print timestamp: 09-May-2022 17:43:24 CEST CONFIDENTIAL