sop sf-1-5.08 sop for training documentation · the sop manual (to include coordination of...

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SOP SF-1-5.08 SOP for Training Documentation

4. SCOPE

4.1. This SOP defines the method for maintaining training requirements and associated documentation for SSF-specific training. IUPUI personnel employment and training requirements, including personnel records are outside of the scope of this SOP. Non-SSF Staff who may perform non-SSF duties in SSF laboratory space are trained per their work unit policies (e.g., IUGB and IUSCC). Non-SSF Staff who perform SSF SOP specific activities (e.g., emergency personnel and personnel from collaborative biorepository groups as identified in the SOP SF-2-3 for controlled access) who need access to the Liquid Nitrogen Freezer Room or SSF contracted consultants) are trained per the applicable SSF SOP and the training is documented per this SOP. For this SOP the term “employee” refers to any personnel who require training per this scope and may be further defined as SSF or non-SSF staff.

4.2. Defines that all “employees” are to be trained in “Good Documentation Practices.”

5. MATERIALS N/A

6. PROCEDURE

6.1. Responsibilities 6.1.1. SSF Director is responsible for ensuring employees receive the proper training to perform

their assigned jobs and for evaluating training needs based on performance and development goals. SSF Director is also responsible for designing an effective training program and assigning qualified trainers for specific functions.

6.1.2. SSF Management is responsible for ensuring employees are properly trained prior to performing assigned tasks.

6.1.3. All SSF personnel may be responsible for training additional staff for procedures in which the SSF personnel member is appropriately trained.

6.1.4. Quality Compliance Specialist is responsible for auditing training documentation, assuring compliance with defined programs, and maintaining consultant CVs.

6.1.5. The SSF Facility Manager is designated as the Individual Responsible for Training (IRT) and maintains and/or performs the following:

6.1.5.1. The SOP Manual (to include coordination of applicable revisions)

6.1.5.2. Training documentation (to include updating and maintaining the training plans, maintaining the training files, and reporting the status of training gaps).

6.1.5.3. Assists personnel in coordinating the completion of their applicable institutional-required training (HIPAA, privacy, and safety) (not applicable to non-SSF staff).

6.1.5.4. Training in Good Documentation Practices consists of a review of the generally recognized practices which are followed to preserve the integrity of data and records. The training includes review of the points below, is provided via training for this SOP, and is recorded on the Prerequisite Training and Signature Form (Appendix A) (This is applicable to non-SSF staff).

6.1.5.4.1. Data is recorded accurately, legibly, contemporaneously and is recorded in indelible ink.

6.1.5.4.2. Data is original and attributable.

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6.1.5.4.3. A single slash is made through spaces intentionally not populated with data. Spaces are not left blank.

6.1.5.4.4. Error corrections are made by a single cross-out (not obliterated), initialed and dated. 6.1.5.4.4.1. Additionally, SSF personnel utilize the following error

codes along with initials and date. (example: EE xxx MM/DD/YY)

6.1.5.4.4.2. EE denotes an entry error (used when hand-written entries must be corrected)

6.1.5.4.4.3. TE denotes a typographical error (used when (“typewritten entries” on forms are erroneous)

6.1.5.4.4.4. CE denotes calculation error (used when a calculation yielded the incorrect result)

6.1.5.4.5. Comments and explanations are provided via numbered footnotes

which are initialed and dated.

6.1.5.4.6. SSF personnel collecting and documenting non SOP-driven information utilize the phrase: “For information only, non-SOP driven” or something similar to distinguish the documentation from that which is required by an SOP.

6.1.5.5. Training in ISBER Best Practices consists of a review of the current version of the ISBER Best Practices or may consist of a review of a document summarizing the current ISBER Best Practices. A copy of the training materials summarizing the ISBER Best Practices is maintained in the SSF. Documentation of training is recorded on the Prerequisite Training and Signature Form (Appendix A) (This is applicable to non-SSF staff)

6.2. Signature Documentation 6.2.1. Prior to completing any official documentation, including training records, all employees

(SSF and non-SSF staff) shall record the following on the Prerequisite Training and Signature Form (Appendix A):

6.2.1.1. Name, Signature, Initials, Start Date, Department, and Position.

6.2.1.2. Signature and date when the prerequisite requirements denoted on the form were fulfilled.

6.2.1.3. SSF Management or Quality Compliance Specialist completes the “Valid Date” on the form.

6.2.2. Updates to the initial information recorded on the Signature Form are recorded on a new form and are filed with the original form indicating a new valid date. When replaced, the original form is invalidated. SSF Management or Quality Compliance Specialist checks the “See new signature form” check-box, and completes the “Invalid Date” and “Reason for Invalidation” sections.

6.2.3. The signature form is invalidated when employment is terminated. For non SSF staff, the form is invalidated when the staff member is no longer responsible for the duties covered by an SSF SOP.

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6.2.4. The original signature forms are filed in the employee’s training binder located in the SSF Operations Office.

6.2.5. The signature form must reflect the format in which the employee initials and signs their name. If more than one format of signature is used, then each must be shown on the signature form. For example, if the full first and last name are used and the full first name, middle initial and full last name are also used, both scenarios are to be captured on the signature form.

6.2.6. Electronic training should be accompanied by electronic signatures per the administering entity.

6.3. Training Files 6.3.1. A training file is maintained for each SSF and non-SSF employee who is trained per this

SOP. Each training file contains the following documents at a minimum: 6.3.1.1. CV, Biosketch or Resume (excluded for non-SSF staff) 6.3.1.2. Certifications & licenses (as applicable - excluded for non-SSF staff) 6.3.1.3. Position Description (Non-SSF staff is limited to identification of affiliation to

a collaborating institution.) 6.3.1.4. Training Plan 6.3.1.5. Completed Training Documentation Form(s) 6.3.1.6. Signature Documentation Form

6.3.2. Personnel may submit updates to their training file at any time to the SSF Operations Manager or Quality Compliance Specialist.

6.4. Safety (Physical, fire, chemical and electrical) and Biosafety Training are managed and documented according to IUPUI policies and are outside the scope of this SOP. SSF specific safety training is managed as directed in this SOP.

6.5. HIPAA and Privacy Training is managed per IUPUI policies and is outside the scope of this SOP.

6.6. Training Requirements (The following training requirements are applicable to SSF staff and non-SSF staff trained on SSF SOPs.)

6.6.1. Initial Training Plan 6.6.1.1. SSF Director or SSF Management determines the initial training plan

including the priorities and the required level of training based on the employee’s qualifications and experience. The training requirements are tailored to the specific job duties initially assigned (and the skill level required for performance).

6.6.1.2. Within one month of hire (or assignment to the SSF), an initial training requirement plan is drafted, provided to and discussed with the employee.

6.6.1.3. All applicable training requirements for each SSF SOP (including a listing of current SOP numbers, title and version per the current table of contents) are listed in the Training Plan as described in section 6.8.

6.6.1.4. Required Level of Training for each assignment: o ‘Read and Understand’ Training (R) o Technical Training (T) o Attend (A)

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o Certification (C) o Pass Testing (P) o Not Applicable (NA)

6.6.1.5. The SSF Director or SSF Management may elect to use an employee’s prior qualifications and experience to satisfy a particular technical training requirement (this does not apply to ‘Read and Understand’ Training). Decisions must be based on the employee’s resume and an in-depth discussion with the employee regarding the specific procedure. They may elect to rescind a decision of this nature at any time based on the employee’s demonstrated performance. Documentation of these decisions is defined in section 6.8.3.

6.6.2. ‘Read and Understand’ Training 6.6.2.1. ‘Read and Understand’ training is assigned for all initial and revised

procedures, and is required prior to or concurrent with requisite technical training. In many cases, Seminar training may be utilized in lieu of ‘Read and Understand’ training. Refer to Section 6.6.2.5.

6.6.2.2. In general, ‘Read and Understand’ training should be limited to a maximum of 4 or 5 SOPs per day.

6.6.2.3. Documentation of this training completion indicates that the trainee has read and understands the procedure, and that any questions have been addressed to the satisfaction of the trainee.

6.6.2.4. In cases where the employee is responsible for execution of the procedure and technical training is not required, completion of ‘Read and Understand’ training documentation indicates that the trainee is qualified to execute the procedure. In situations where ‘Read and Understand’ training is being performed due to an SOP revision, the SOP revision form indicates whether additional technical training is required for the revised SOP.

6.6.2.5. ‘Read and Understand’ training is documented by the trainee on the SSF ‘Read and Understand’ Training Form (Appendix C). The trainee enters their initials and the date of completion on the form.

6.6.2.5.1. Alternatively, seminar training (per section 6.6.4) is permitted as an acceptable means for documenting training except for the initial training of SSF personnel and collaborating biobank personnel, in which case Read/Understand training must be performed and documented. Seminar training may be used to supplement the Read/Understand training of new personnel, but may not be used as a substitute for Read/Understand training.

6.6.3. Technical Training 6.6.3.1. Technical training is assigned for procedures which require more than ‘Read

and Understand’ training to ensure competency of the individual. Refer to Appendix G for a list of procedures requiring Technical Training (Note: Technical training on a procedure other than what is listed on Appendix G may be conducted and documented as necessary at the discretion of SSF Management).

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6.6.3.2. Technical training must address the following:

6.6.3.2.1. Observing qualified personnel perform the procedure (Demonstration / Shadowing).

6.6.3.2.2. Performing the procedure correctly with oversight.

6.6.3.3. Some procedures may only need to be demonstrated once (i.e., cleaning procedures). Other procedures may require demonstration more than once or shadowing for a period of time depending upon the complexity of the procedure and the employee’s ability to grasp the procedural nuances involved.

6.6.3.4. After the procedure has been demonstrated, the employee will perform the procedure under the direct supervision of the trainer until the trainer is satisfied that the trainee can perform the procedure correctly.

6.6.3.5. The completion of the training is defined by the trainer signing the Technical Training form. This indicates that the employee is competent and qualified to execute the procedure without further oversight.

6.6.3.6. Technical Training is documented on the SSF Technical Training Form (Appendix D). Documentation generated for technical training is co-signed by both the trainee and the trainer. The form is reviewed by a member of the SSF management team; this signature only indicates that the form has been completed correctly and they are in agreement with the level of training performed.

6.6.3.7. In the situation where a member of the SSF management team is being trained by another SSF member, provided the trainer has signed off on the technical training form, it is permissible for the SSF management member to sign as the reviewer of the SSF Technical training form as their signature only reflects that the form was completed correctly as described in 6.6.3.6 above.

6.6.3.8. In some cases, seminar training may be used to satisfy technical training requirements and will be evaluated on a case-by-case basis by SSF management. Example: equipment operation training provided by the Original Equipment Manufacturer (OEM). Documentation of this training may be on any form given by the organization providing training or any relevant SSF training form providing there is indication of the requirement it satisfies.

6.6.4. Seminar Training 6.6.4.1. Seminar training is a method of training provided to a group of individuals by

a designated trainer. Examples of seminar training include:

6.6.4.1.1. Industry, compliance or technical training provided by an external organization

6.6.4.1.2. Training sessions and conferences provided internally that may or may not be related to a specific SSF SOP

6.6.4.1.3. SSF personnel provide seminar training to summarize important SOP concepts for all collaborating biobank personnel as follows:

6.6.4.1.3.1. Initial SOP training for new staff.

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6.6.4.1.3.2. In response to SOP revisions.

6.6.4.1.3.3. In response to facility needs (i.e. deviations).

6.6.4.1.3.4. Refresher training as needed and/or as deemed necessary by SSF.

6.6.4.2. Seminar Training performed internally is documented on the SSF Seminar Training Form (Appendix E). If the training organization provides a seminar training document specific to the date of training, that document may be included in the training record in lieu of additional documentation.

6.6.4.3. The training scope is recorded on Appendix E, or a copy of the training presentation or agenda from internal Seminar Training may be included with the training form.

6.6.5. Continuing Education 6.6.5.1. Continuing Education includes, but is not limited to, additional actions

relevant to the individual’s position and involvement within the organization. Types of activities which qualify as continuing education are:

6.6.5.1.1. Involvement in specific projects or committees within the institution or professional organizations

6.6.5.1.2. Attendance at meetings where relevant topics are discussed 6.6.5.1.3. Institutional & Departmental training

6.6.5.1.4. Reading regulatory documents, industry guidance and technical journals

6.6.5.1.5. Attending classroom training provided by reputable organizations

6.6.5.1.6. Providing professional training or presentations

6.6.5.1.7. Significant contributions to scientific posters or publications

6.6.5.2. SSF does not have formal continuing education requirements applicable to SSF employment. Therefore, documentation of continuing education is optional but may be documented on the SSF Continuing Education Log (Appendix F). Certificates of attendance and other forms of documentation may also be included in the training files to satisfy continuing education documentation.

6.6.5.3. When attendance at meetings is indicative of training, attendance of recurrent meetings may be documented via a single entry. Attendance of non-recurrent meetings is documented via individual entries. Records of attendance, agendas, meeting minutes and other documentation attached to the training form provide sufficient evidence of attendance.

6.7. QUALIFICATION OF TRAINERS

6.7.1. Any trained individual may act as a trainer, and training assignments are made by SSF management. Trainers must also have completed and documented training on SOP SF-1-5 (this SOP).

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6.8. TRAINING REQUIREMENT EXCEPTIONS

6.8.1. ‘Read and Understand’ Training 6.8.1.1. Personnel who have signatory approval on the SOP do not require additional

‘Read and Understand’ Training.

6.8.2. Technical Training 6.8.2.1. Technical training may be satisfied when an employee has signatory approval

on an SOP or by virtue of prior qualifications and experience as defined in section 6.6.1.5.

6.8.3. Documentation of Exceptions 6.8.3.1. Satisfaction of technical training requirements is described in section 6.6.3.

All exceptions are noted via Memo-to-File indicating the rationale for exemption from training. Exemptions require approval from SSF Management.

6.9. TRAINING PLAN MANAGEMENT

6.9.1. Training Plan Maintenance 6.9.1.1. The Training Plan (Appendix B) is used for new employee training.

6.9.1.2. Training requirements for the new employee are noted by SSF Management prior to initial training.

6.9.1.3. Training consists of SSF Management review directly with the employee with opportunity for questions and discussion for all required SOPs.

6.9.1.4. The Training Plan is printed and initialed by the trainer to document completion of training per 6.9.1.3 for the respective SOPs and is filed in the Employee Training Binder.

6.9.2. Procedural Updates 6.9.2.1. If procedural changes are minor, retraining on the revised procedure will be

done at the level of ‘Read and Understand’ and documented as indicated in Sections 6.6.2 and 6.6.3. If the procedural changes are major, the retraining may include technical training similar to that done with the original procedure.

6.9.2.2. Training requirements for new and revised procedures are assessed by SSF management and quality assurance and are documented on the associated Change Control forms, (SF-1-6 Appendix C SSF Document Change Control Form).

6.9.3. Re-training 6.9.3.1. Retraining may be required based on performance, required as a corrective or

preventative action associated with an audit, deviation or other excursion, or other appropriate reason. Retraining may also be requested by an employee for clarification.

6.9.3.2. SSF management will determine when individual performance-based retraining is required and what type of re-training is needed based on the complexity of the process or procedure and the events leading up to the need.

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6.9.3.3. Details of the re-training requirements are recorded in the comment section of the applicable training form.

6.9.4. Control of Changes 6.9.4.1. SSF management evaluates individual training requirements each time

changes in assignment of new responsibilities occurs. Updates are communicated to the employee.

6.9.4.2. When employees are assigned functions which they have not executed during the previous calendar year, they are required at a minimum, to re-read the procedure and document the ‘Read and Understand’ training prior to implementing. These employees are encouraged to shadow qualified team members and request additional re-training when needed. Signatory on an SOP revision in the previous year satisfies this requirement.

6.9.4.3. When new SSF staff members are hired, evaluate the need to add the new personnel on a corresponding revision to SF-1-13 (SOP for Housing GLP Collections) based on the intended role of personnel hired.

6.9.5. Archival of Training Records 6.9.5.1. When employment is terminated, the signature form is invalidated as

described in Step 6.2.3. 6.9.5.2. Training files for terminated employees are reviewed for completeness and

are moved stored/archived for the retention period defined in SOP SF-1-6 SOP for Controlled Document Management.

7. REFERENCES 7.1. ISBER Best Practices (current version)

8. DOCUMENTATION 8.1. Training files for current and inactive employees are retained in the SSF Operation’s office per

the SOP for Controlled Document Management (SF-1-6). 8.2. Deviations are managed per SOP SF-1-9 Deviation Management.

9. APPENDICES

9.1. The current version of the following appendices are used to implement this SOP: Appendix A: SSF Prerequisite Training and Signature Form (1 Page) Appendix B: SSF Training Plan (1 Page) Appendix C: SSF ‘Read and Understand’ Training Form (1 Page) Appendix D: SSF Technical Training Form (1 Page) Appendix E: SSF Seminar Training Form (1 Page) Appendix F: SSF Continuing Education Log (1 Page) Appendix G: SSF Technical Training Requirements (1 Page)

APPENDIX A Page 1 of 1

SOP SF-1-5 SOP for Training Documentation Form Version 04

Prerequisite Training and Signature Form***

To be completed by employee: Name: □ See new Signature Form Signature: Initials: Start Date: Department: Position: Prerequisite Training: (Applicable for initial signature form only.) □ I have completed and understand Good Documentation Practices (SF-1-5 point 6.1.5.4) □ I have reviewed the current version of ISBER Best Practices for Repositories □ I understand that regular training is required and regular checking of work does not suggest doubt in my

ability to perform but is a part of regular practice for ensuring quality. Signature: Date =========================================================================== To be completed SSF Management or Quality Compliance Specialist: Valid Date: Reviewed by (Initial/Date): Invalid Date: Reason for Invalidation: Terminated Other (Define)___________________________ Reviewed by (Initial/Date): ***This form MUST be completed by the employee and validated by either SSF Management or the Quality Compliance Specialist BEFORE the employee can add official documentation to any SSF forms, including personnel training forms supplied in this SOP.

APPENDIX B Page 1 of 1


SSF Training Plan Page _____ of ________

Name: Position:

(Note: Training Requirements are determined by SSF Supervisory personnel based on the anticipated duties for the respective job/position, and using the SOP Table of Contents to obtain the list of SOP versions currently effective.) Key: R = Read and Understand Training; T = Technical Training: A = Attend; C = Certification; P = Pass Test; NA = Not Applicable (Note: refer to Appendix G for procedures requiring technical training) 1 “Date Completed” is the date upon which SSF Supervisory personnel have provided an overview of the procedure with the trainee. All required training (Read/Understand, Technical, etc.) is performed and documented by the trainee on Appendix C, D, E or F as appropriate.

SOP / Document Number

Version SOP / Document Title Training Required (see Key)

Date Completed1

(Trainer’s Initials/Date)

APPENDIX C Page 1 of 1


SSF READ AND UNDERSTAND TRAINING FORM

DOCUMENT NUMBER VERSION DOCUMENT NAME Employee Initial* /

Date 1.

2.

3.

4.

5.

6.

7

.8

9.

Comments:

* I have read and understood the Procedures listed on this document, have had an opportunity to discuss them and have my questions answered.

Trainee Name: _________________________________________________________

APPENDIX D Page 1 of 1


SSF TECHNICAL TRAINING FORM

□ Training □ Retraining Trainee Name: SOP Number & Version:

Technical Procedure Identification (refer to Appendix G if applicable): Observing a Technical Procedure (Trainer demonstrates procedure per Appendix G to trainee):

Date of Demonstration: _____________ Name/s of Demonstrator/s:___________________________________________ Description of procedure demonstrated per Appendix G (if applicable):

Initials/Date:________________

Performing a Technical Procedure with Oversight (Trainee performs procedure per Appendix G for trainer):

Date of Performance: _____________ Name/s of Observer/s:___________________________________________ Description of procedure performed per Appendix G (if applicable):

Initials/Date:________________

Trainer/Trainee Comments:

Training Completion Date:__________________

Trainee Signature: __________________________ Date:____________ Trainer Signature: ___________________________ Date:_______________ Reviewed By SSF Management: ____________________________ Date:_______________

APPENDIX E Page 1 of 1


SSF SEMINAR TRAINING FORM TRAINING TITLE:

TRAINING SCOPE:

TRAINING DATE: TRAINER NAME/AFFILIATION (PRINT): TRAINER SIGNATURE

TRAINEE NAME (PRINT) TRAINEE SIGNATURE 1.

2.

3.

4

5.

6.

7.

8.

9

10.

Comments:

APPENDIX F Page 1 of 1


SSF CONTINUING EDUCATION LOG

Employee’s Name:

Title of Meeting/Activity Description of Activity

Enter Dates or

Frequency of Attendance

Additional Information Initials/ Date

1.

2.

3.

4.

5.

6.

7.

APPENDIX G Page 1 of 1


SSF TECHNICAL TRAINING REQUIREMENTS

*Note: This is a list of SOP procedures requiring technical training. Additional procedures may be trained on and documented at the discretion of SSF Management*

SOP: SF-2-4 Alarm System Management and

Response Procedure: Alarm wire preparation and

installation Trainer demonstrates the following to trainee:

a. Prepare an alarm wire by removing the appropriate plastic casings without cutting through the wires.

b. Connect the wire to the alarm contact points of a specimen storage unit.

Trainer observes the trainee successfully perform the following:

a. Prepare an alarm wire by removing the appropriate plastic casings without cutting through the wires.

b. Connect the wire to the alarm contact points of a specimen storage unit.

SOP: SF-3-9 Emergency Escape Breathing

Apparatus Procedure: EEBA operation Trainer demonstrates the following to trainee:

a. Don the EEBA. b. Operate the EEBA by opening cylinder

valve and adjusting hood per this SOP. Trainer observes the trainee successfully perform the following:

a. Don the EEBA. b. Operate the EEBA by opening cylinder

valve and adjusting hood per this SOP.

SOP: SF-3-15 Personal O2 Monitors (Drager

Pac 5500) Procedure: Personal O2 monitor operation Trainer demonstrates the following to trainee:

a. Turn on the O2 monitor. b. Respond to low and high alarms. c. Turn off the O2 monitor.


a. Turn on the O2 monitor. b. Respond to low and high alarms. c. Turn off the O2 monitor.

SOP: SF-4-16 DNA Quality Control

Procedure: Nanodrop operation for performing analyses on DNA specimens

Trainer demonstrates the following to trainee: a. Load and navigate Nanodrop software. b. Make a blank measurement. c. Measure a sample for concentration and

purity. d. Save and store the data.


a. Load and navigate Nanodrop software. b. Make a blank measurement. c. Measure a sample for concentration and

purity. d. Save and store the data.

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