Patients With Als Survey (Pals) Site Delegation Log printable pdf download

Patients With Als Survey (Pals) Site Delegation Log

Page ______ of ______

ALS S

(PALS) S

ATIENTS WITH

URVEY

ITE

ELEGATION

Principal Investigator:

Protocol/Site #:

START

RINT

AME

ITLE

IGNATURE

INITIALS

STUDY TASKS

END DATE

DATE

List individual delegated study related tasks (ICH GCP 4.1.5). Signature

*Delegated Study Tasks:

and initials are required of all persons authorized to make entries and/or

corrections on CRFs/data collection forms, all supporting personnel and

1. Obtain Informed Consent

8. Finalized potential subject

12. Other:

all sub-investigators listed on the Form FDA 1572 (if applicable). Update

2. Enter survey

lists

13: Other:

this log in a timely manner as new personnel are added and/or study roles

3. CRF Queries

9. Contact potential subjects

change.

Personnel needing to sign:

4. Maintain Regulatory Docs

10. Pull needed data from EMR

PI: ALS specific physician responsible for oversight at their location

5. Maintain IRB documents

for analysis

Co-I: Physicians at each specific site that will be involved in the study.

6. Data Monitoring

11. Mail surveys

Point of contact: Study nurse, study coordinator – person that is the main

7. Pull name of potential subjects

point of contact at each GPC site.

from EMR

Honest Broker: Each GPC site EMR person responsible for pulling list.

PI Signature (Close Out):

Date:

Patients With Als Survey (Pals) Site Delegation Log

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