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DATABASE AND RECORD RETENTION TO

ASSIST PUBLICATION PLANNERS

Laura L McCormick, PhD

Senior Vice President

ProEd Communications, Inc │ An Omnicom Company

June 27, 2012

ISMPP ANNOUNCEMENTS

• Mark your calendars! The 2013 European Meeting of ISMPP is

on 22–23 January 2013, ETC Venues, 200 Aldersgate, St Paul's,

London, UK

• Call for Abstracts is now open for the 2013 European Meeting.

Submission deadline is October 12th at 5:00pm EST.

• This program qualifies for 1 credit towards recertification

• Applications are now being accepted for the September CMPP

exam. Deadline for submission is August 15th. Visit the ISMPP

website for more information.

• Speaker: Laura McCormick (PhD) is Senior Vice President and Associate

Practice Leader for Scientific Communications at ProEd Communications

• Moderator: Manon Boisclair (MSc, RN, CMPP) is Director of Global

Scientific Communications—Myeloma Franchise at Celgene Corporation.

She is also an ISMPP University Committee member

Introduction

• Dr. McCormick oversees publications practice processes and policy for

ProEd and other HCG network companies. Her therapeutic areas of

expertise include allergy/immune-mediated diseases and oncology.

• Since joining ProEd in 2000, she has overseen content development and

process implementation for over 25 publication plans for a number of

pharma partners involving more than 300 manuscripts, countless congress

presentations and stand-alone meetings.

Speaker’s Short Bio

Disclosures

• Information presented reflects my personal knowledge and

opinion and does not represent those of my current or past

employers or those of the ISMPP

• Content presented includes guidance with legal implications

– I am not a lawyer and cannot guarantee the accuracy of legal

information

Today’s Objectives

• Understand the scope of document retention for publication

planning

– What to keep (type of documents)

– What not to keep

• Recognize the duration documents should be retained

• Understand best practices for document retention related to

Publications

• Understand changes in practices based on Corporate Integrity

Agreements (CIA) with the United States Office of the Inspector

General (OIG)

• Rationale for records retention

– Legal requirements

– Compliance documentation (OIG, ICMJE)

– Good management practice

• Types of records to retain for Publication planning and execution

– GPP2 and ICMJE compliance documentation

• Author letter

• Document reviews

– Draft copies

– Important correspondence

– Critical notes

Presentation Outline (1)

• Methods for record retention

– Proprietary databases

– Spreadsheets and other databases

• Duration of records for retention

– Legal requirements

– Practical aspects

Presentation Outline (2)

Background

• Corporate records hot topic: Sarbanes Oxley Act (SOX)

– Virtually every type of business document must be retained for a period

of time including e-mails, memos, work products, etc

• HIPAA regulates the manner in which personal information can

be stored

• Corporate Integrity Agreements (CIA) mandate records

• Purpose: Evidence that a business has complied with statutory

requirements under particular statutes

• Evidence is a record that clearly identifies relevant details

HIPAA = Health Insurance Portability and Accountability Act

Document Retention for Scientific Communications: Frame of Reference

• What is our frame of reference for today?

– Healthcare industry-sponsored publications

• Manuscripts: Primary/secondary/review/supplements

• Congress presentations: Abstracts/Posters/Orals

• Book chapters

• Other published materials subject to peer review and/or

ICMJE criteria for authorship

Legal Aspects of Document Retention

• How long should documents be retained?

– Most frequent guidance is duration of contract plus 7 years*

– My organization requires retention for lifetime of the active contract +

10 years; many pharmaceutical companies require contract + 10

– State laws govern retention of medical records, continuing medical

education, and other records

– Records management: Timeframe for retention of types of documents

varies by document types

• Refer to state and company regulations

• Follow your company’s and client’s policy for record retention and disposal *Rule of thumb: retain documents for active contract timeframe + 7 years or according to your institution’s or your client’s standards

(whichever is longest).

Legal Aspects of Document Retention

• Personal information cannot be maintained in widely accessible databases

or servers (locked or password protected files) according to federal privacy

laws and HIPAA

– Social security numbers

– Bank routing numbers

– Medical records

• Retained documents are “discoverable”

*Rule of thumb: retain documents for active contract timeframe + 7 years or according to your institution’s or your client’s standards

(whichever is longest).

Is this relevant to

Publications Management?

Consequences of Improper Document

Retention • Poorly organized, improper, or excessive document retention can result in

– False perceptions of compliance

– Loss of revenue (related to work hours)

– Violation of CIA issued by OIG

– Personal/corporate liability

• Retention of personal information (social sec # or bank routing #) or

medical information within compliance programs (ie, names on a scan)

violates US federal laws and HIPAA

• Intentional destruction of business records can constitute a criminal act

CIA = corporate integrity agreement; OIG = Office of the Inspector General

Scientific Communications Records: Types of Documents (1) • Physician/Author agreementsa, investigator/research contract,

study charter

• Manuscript/abstract/poster/slides drafts (content outline, each

draft)

– Retain each version circulated for reviewa

• Guidance on content (author, sponsor, any other)a

• Disclosures

– Financial

– Conflict of interest

aMaintain within compliance database if applicable

Scientific Communications Records: Types of Documents (2) • Correspondencea

– Author

– Expert consultant or statistician

– Sponsor

– Journal

• Copyright documents

– Signed agreements

– Permission to adapt or reproduce

• Letters of acceptance/rejectionb, solicitation letter to journal

a Include level of detail necessary to accurately reflect content guidance received from all involved parties within compliance database.

b Maintain within compliance database if applicable

Scientific Communications Records: Types of Documents (3)

• Contracts (stats analysis, clinical interpretation) or any evidence

of payment

• Other compliance documentationa

– E-mails to clarify miscommunications

– Documentation to correct compliance violations

• Any other document related to legal or compliance mattersa

• Notes regarding actions taken, advice given, etc.

• Documentation of audits performed (internal/external)

aMaintain within compliance database if applicable

Scientific Communications Records: Types of Documents (4)

• Source Data to document data accuracy

– All patient data, scans, images, etc., must be “de-identified”

– Privacy laws vary globally

• Extra vigilance is necessary when physicians e-mail images

aMaintain within compliance database if applicable

How Much is Enough?

• Should you retain

– Every e-mail?

– Every manuscript draft?

• Should you upload all project documents, notes, queries into

compliance management programs?

How Much is Enough?

• Remember CIAs (typically) stipulate routine audits!

– Routine compliance officer audits

• Author and other reviewer comments

• Author contract/letter (correct level of involvement)

• Identification of missing information (notes, dates, contracts, etc.)

• Interim and final submitted document versions

– Random OIG audits

• Including details that are irrelevant to documentation of accurate

business records and/or compliance could complicate the audit

How Much is Enough? General Guidelines

• Content documents (ie, manuscripts, abstracts)

– Each relevant milestone (CO, 1st draft and subsequent drafts circulated

for review, submitted draft)

– All comments regardless of source

– Verbal content direction (minutes/notes from author TC)

How Much is Enough? General Guidelines • Correspondence

– Notable communications (ie, clarifying authorship or author order,

comments in e-mails, controversial topics, key decisions)

– Communications clarifying an e-mail that could be misinterpreted as a

compliance violation

– Most organizations auto-delete e-mail

• Archive e-mails that constitute business records within project server or

compliance database (ie, those that relate to compliance, direction, etc.)

Some Special Notes About E-mails • Should the communication be conducted in writing?

– In sticky situations it is wise to pick up the phone: correspondence can

be misleading if not all facts are correct

• Consider who should be copied on sensitive communications

• Should sensitive e-mails receive a reply or be forwarded to

others?

– For sensitive topics consider the consequences of an e-mail being read

out of context? Will it still make sense?

– Always clarify communications that could create a misperception

Methods for Document Retention

• Proprietary databases

– Datavision

– Sylogent

– Please Review

– Others

• Excel spreadsheets

• Well-organized server folder structure

Compliance

Document Retention = Compliance

Compliance

• Document retention can never replace Good Publication

Practice (GPP2)

• BUT proper documentation can

– Capture compliance violations

– Demonstrate compliance with company policies, CIA, and

GPP2/ICMJE

Developing SOPs For Publication Document Retention

• Know your company’s policy

• Know your client’s policies

• Conduct annual training

– Document retention

– Publication database management

– Communication etiquette

Document Retention Best Practices:

Conclusions

• Comprehensive knowledge of document retention and

destruction policies of your employer and clients is important for

publication planning professionals

• Retention of records that accurately reflect author involvement,

publication draft milestones, content direction, contracting, and

adherence with CIA and company policies is critical

Document Retention Best Practices: Conclusions • Organization of records is a must!

– Saves time/money

– Reduces compliance officer effort

• For specific guidance, refer to company/client policies regarding

– Type of records to retain

• Specific caveats regarding correspondence and notes/minutes

– Duration of record retention

– Records destruction

QUESTIONS......

To ask a question, please type your query into the

‘Q&A’ chat box at the bottom left of your screen.

Every attempt will be made to answer all questions.

THANK YOU

Laura L McCormick, PhD

Senior Vice President

ProEd Communications, Inc │ An Omnicom Company

NEXT ISMPP U

• Date: Wednesday, July 25th

• Topic: Introducing ORCID (Open Researcher &

Contributor ID): How to Use this Novel and Independent

Author/Contributor Disambiguation System to Simplify

Manuscript Submission and Processing

• Speaker: Laure Haak, PhD, Executive Director, ORCID

• Moderator: Tim Bacon, CMPP; CEO, Medicine in Practice, Inc.

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