Technical Report Style Guide For Authors

Transcription

1 Parenteral Drug Association Technical Report Style Guide For Authors December 2016 PDA.org Page 0 of 18

2 TABLE OF CONTENTS Preface... 3 Style Guides and Resources... 3 Introduction... 3 Writing the Technical Report... 3 TECHNICAL REPORT TEMPLATE... 3 LENGTH OF TECHNICAL REPORT... 3 Structure of Technical Report... 4 Cover Page... 4 Table of Contents Introduction Purpose Scope Glossary Body of the Report References... 6 WHAT TO REFERENCE... 7 HOW TO REFERENCE QUOTATION MARKS... 7 Writing Style... 8 COMMUNICATION BASICS... 8 SENTENCE STRUCTURE... 8 PARAGRAPHS... 8 VOICE, TONE, AND STYLE... 8 POINT OF VIEW... 9 ACTIVE VS. PASSIVE VOICE... 9 CONCISE LANGUAGE... 9 HYPHENATION... 9 LISTS NUMBERS VS. BULLETS CAPITALIZATION EUROPEAN VS. WESTERN SPELLING ACRONYMS FIGURES AND TABLES PRODUCTION PROOFS References Appendix 1: PDA Technical Report Reference Guide Appendix 2: Quick Reference Grammar and Punctuation Guide PDA.org Page 1 of 28

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4 Preface This document is designed to provide direction and advice to PDA Technical Report Teams (TRT) who are sharing their knowledge with their peers through the technical report development process. The goal is to produce a concise, science-based, readable report that will advance industry practices. This style guide can be used in conjunction with the Technical Report Template as a convenient reference to facilitate the writing process. The TRT Leader(s), working with the PDA scientific and regulatory affairs (S&RA) staff, should strive to follow the guidance in this document in order to ensure that high-quality documents, with a consistent voice and the PDA brand, are published. The resources used to prepare this manual were selected for applicability and accessibility for PDA members: Chicago Manual of Style, The ACS Style Guide, ISO 690 Guidelines for Bibliographic References and Citations, and Purdue Online Writing Lab. Where guidance is not based on these resources, the source is provided. Style Guides and Resources The resources discussed below were used as the primary resources for writing this style guide and may provide further guidance on editorial style for the content of PDA technical reports. Abbreviations, Formulas, and Terms. The American Chemical Society (ACS) Style Guide provides advice on using abbreviations and acronyms; formatting equations and math; representing physical and chemical terms, compounds, and notations; and using related parentheses and brackets in a sentence. When the ACS Guide differs from specific standards used by the pharmaceutical and biopharmaceutical industry, the industry standard applies. For all other content and formatting, including computer terms, the Chicago Manual of Style (16th Ed., 2010) or the Chicago Manual of Style Online ( is preferred. References and Citations. PDA uses the ISO 690 Numerical Reference system for formatting source information. The PDA Technical Report Reference Guide provides general information on formatting references and how to use the References/Citation function in Microsoft (MS) Word to enter and manage source information. Spelling. Generally, PDA follows the Merriman-Webster online dictionary ( for spelling; however, when a word is used as an industry standard, the industry standard applies. PDA.org Page 3 of 28

5 PDA Technical Report Style Guide Introduction This style guide, used in conjunction with the Technical Report Template, provides a resource to those writing technical reports published by the Parenteral Drug Association (PDA). PDA members highly value these technical reports because they offer expert guidance and opinions on important scientific and regulatory topics. They are peer-reviewed, global-consensus documents written by subject matter experts on issues relating to a wide array of challenging technical areas. PDA technical reports are used as essential references by industry and regulatory authorities around the world. The TRT is expected to complete a working draft of their technical report within the 18-month cycle indicated in Figure 1. The PDA Technical Report Team Handbook and TR Team Training presentation provided on the online collaborative workspace describe the process in more detail. Figure 1. Technical Report Cycle Writing the Technical Report TECHNICAL REPORT TEMPLATE TRT members draft the PDA technical report using a customized template developed in MS Word that is supplied by the S&RA staff on the TRT s PDA Workspace. The Technical Report Template outlines all the necessary components needed to develop the report in a preset format. LENGTH OF TECHNICAL REPORT Technical reports should be no longer than 60 pages, maintaining the preset template fonts and margins. Should a report surpass the recommended length, there are a few methods that can be employed to reduce content: Eliminate unnecessary or extensive quoting, particularly from government guidances or other PDA technical reports, by citing the document instead Replace dense text with a clear figure or table Omit any figures and tables that do not enhance the text Omit multiple occurrences of repeated figures or blocks of text, such as steps or processes, by adding a reference to the first occurrence Move repeated figures or blocks of text to an appendix and reference it in the body of the report. PDA.org Page 3 of 18 PDA.org Page 4 of 28

6 If it becomes evident that 60 pages in not adequate to cover the topics of the project, TRTs are strongly encouraged to create a series of reports. The S&RA can assist teams in developing distinct topical reports in a logical progression. Structure of Technical Report The TRT will be supplied with a template that includes all the sections required to develop a technical report, as listed in Figure 2. Additional Reading and Appendix sections are optional. Cover Page Table of Contents 1.0 Introduction 1.1 Purpose 1.2 Scope 2.0 Glossary 2.1 Abbreviations (optional) 3.0 Body of Work (Section 3.0, 4.0, etc.) 4.0 References 5.0 Additional Reading (optional) 6.0 Appendices (optional) Figure 2. Typical Structure of a PDA Technical Report Cover Page The TR Team supplies a title for the technical report and the names of the authors. The TRT Leader maintains an up-to-date list that includes the correct spelling of each person s name, title, current affiliation, academic degrees, and contact information. Only advanced degrees are included (e.g., JD, MD, PhD, DVM, PharmD, etc.). Table of Contents The TRT builds the Table of Contents and Scope statement at the start of the technical report development process. The Table of Contents lists the top three level headings of the report body and their page numbers for quick identification of specific topics. Each chapter is numbered sequentially according to the Technical Report Template numbering system. By using the MS Word styles imbedded in the template, the Table of Contents can be generated and updated automatically. 1.0 Introduction The total length of the Introduction section, including the Purpose and Scope subsections, should be no longer than one-and-a-half pages. PDA.org Page 5 of 28

7 The Introduction presents the technical report topic to the reader and places it in context. Example: Pharmaceutical companies and suppliers often make quality decisions based on visual inspections of packaging components without the aid of universal guidelines or standards. However, the industry lacks an approach to a quality decision-making process for identifying and classifying visual nonconformities for elastomer components and aluminum seals. The first paragraph should explain the issue and its significance, and briefly summarize any historical or background information. Discussion can describe any gaps in existing information, research, etc., and support it with source information from published PDA technical reports or other works. Example: Historical surveys of cell lines have found high rates of mycoplasma contamination in research labs and production facilities (1; 2). There should be no lists, definitions, or details in this section. 1.1 Purpose The Purpose subsection outlines the challenge being addressed and describes how the report will address that challenge. Example: This document serves to complement the information provided in PDA Technical Reports TR39, TR58, and TR64 by describing in more detail the qualification and operational use of passive thermal protection systems (1; 2; 3). There should be no lists, definitions, or details in this subsection. 1.2 Scope The Scope subsection clearly defines the content of the report and can describe any exceptions, limitations, exclusions, or specific inclusions. It may include statements of intended use or broadly identify how the material in the report is organized. When useful of necessary, the TRT can also include an out of scope statement that describes explicitly what is not covered related to the topic. Example 1: No attempt is made to encompass all types of unit operations for which reprocessing could be considered. Example 2: Diagnostics and components, such as blood collection stoppers and needle sleeves used to collect blood, and medical device components such as gaskets, diaphragms, and O-rings, are out of the scope of this report. There should be no lists, definitions, or details in this subsection. PDA.org Page 6 of 28

8 2.0 Glossary The Glossary includes a list of common terms specific to the technical report topic. Definitions of terms are listed alphabetically and should come from official sources such as the U.S. Pharmacopeia (USP), American Society for Testing Materials (ASTM), International Conference on Harmonisation (ICH), International Organization for Standardization (ISO), or other PDA technical reports. For consistency, using definitions from existing PDA technical reports is preferred; the S&RA staff is developing a master glossary of terms used in current technical reports that will be made available to members. Definitions quoted from other sources should be cited at the end of the definition and the source information should be included in the References section. A subsection can be added, if needed, to list acronyms that are used throughout a report. Examples are provided in the template. 3.0 Body of the Report The TRT develops the body of the report according to the defined Scope, expounding on statements made in the Introduction and providing supporting details. Information can be presented in text, tables, and bulleted or numbered lists; figures and graphs that enhance the content of the report can be included as well. Using a consistent style to present the material (e.g., lists, bullets, etc.) contributes to the flow and readability of the report. The Technical Report Template formats text in the style where it is entered. To add a section beyond those presented in the template and format it in the same manner: 1. Type the new section heading into the text and leave the cursor there 2. Move your pointer to the Styles group on the Home Tab 3. Click on the drop down list to reveal heading and text styles 4. Click on the heading level or type of text for the chosen content 5. The text should change to the style chosen (Figure 3). Figure 3. Use the Styles group in MS Word to format sections added to Technical Report Template Headings and text may change as the document develops. The S&RA staff will review the final draft technical report to make sure the content is sequenced correctly. If an Appendix section is added to the technical report, it should supply related, supplementary information and should be identified in the body of the text. Appendices are considered standalone documents, so each appendix should include its own References section, if needed. 4.0 References The References section is numbered sequentially following the last section of the content. This single section includes citations from the body of the document; the references are not listed by section nor are references from any appendices included. PDA.org Page 7 of 28

9 Source documents can be added to the technical report at any time using the automated MS Word citation tool. PDA uses the ISO 690 Numerical style format. A copy of the PDA Technical Report Reference Guide, containing illustrated instructions on how to insert citations using the MS Word citation tool, is attached as Appendix 1. Note: Wikipedia is not considered a reliable reference source and should not be used for PDA technical reports. If the technical report includes an Additional Reading section, it should be formatted in the same manner as the References section, but should not duplicate any of the References material. The TRT Leader(s) must ensure that all references and sources presented in the technical report are accurate, complete, and current prior to finalizing the draft report for acceptance reviews. WHAT TO REFERENCE To recognize the work of others incorporated into the report paraphrased content, direct quotations, graphics, etc. the text should be identified with a reference. This applies to any material that is not original work or is outside the fair use guidelines (1), including public use documents, such as Food and Drug Administration guidances or ICH quality guidelines. Commonly known or readily verifiable facts, proverbs, and other familiar expressions can be stated without quotation or attribution, unless the wording is taken directly from another source. The citation should be inserted close to the referenced text. If the reference applies to a specific word, words, phrase, or quote within a sentence, the citation is inserted immediately after the quote. If the reference refers to an entire sentence, paragraph, or passage, the citation should be inserted immediately before the period at the end of the last sentence, e.g., (#). HOW TO REFERENCE QUOTATION MARKS Quotation marks should be used to denote content or terms used verbatim, using only as much of a quotation as is needed to convey the message. For quotes fewer than three lines: Use double quotation marks (" ") around a sentence or group of words quoted in the text and always provide the source for the quoted material in a citation, e.g., (#). Use single quotation marks (' ') when enclosing a quote within a quote. Use double quotation marks around a single special word or term the first time it is used, but not for subsequent occurrences; if the special word or term is hyphenated, no quotation marks are used. Periods and commas stay inside the quotation marks; colons, semi-colons, exclamation points, and question marks go outside the quotation marks, unless they are part of the quoted material. Note: The British style of quotation reverses the double/single quotation marks rule, as does the style of many other countries. PDA follows American rules of punctuation. Quotations of three or more lines should be placed in a separate, indented paragraph using italic type; no quotation marks are needed. The source should be placed at the end of the last sentence. When paraphrasing another s work, no quotes are used; however, the source should be cited at the end of the material paraphrased, e.g., (#). Italics can be used to denote emphasis, rather than enclosing common words in quotation marks. PDA.org Page 8 of 28

10 Writing Style COMMUNICATION BASICS For effective communication, a message needs to be clear, concise, consistent, and usercentered. The purpose of technical writing is generally to communicate complex ideas, concepts, processes, or procedures. In order to do so, writers first need have a clear idea who their audience is and the purpose the document will serve. Fundamentally, the members of the TRT need to make sure the PDA technical report is clear and easy for the intended audience to understand so the information it contains can be put into practice. In other words, writers should provide the information their readers need in a manner they understand, in as few words as possible, and in the same voice and verb tense. SENTENCE STRUCTURE Good technical writing uses short, concise statements and avoids synonyms. Following these general guidelines should keep the message from getting lost in rhetoric. If a sentence is the length of a paragraph, consider breaking it into two sentences. When using compound sentences, make sure the structure and meaning of each clause is understandable and the relationship between the clauses is logical. Vary sentence length, especially for long spans of continuous text. When describing steps or actions to perform, try to keep sentence length to approximately 15 words. Put familiar information at the beginning of a sentence and introduce new, complex information at the end of the sentence. When using a pronoun, make sure it is clear what noun it is replacing. Keep modifiers words, phrases, clauses near the subject or verb they modify to avoid ambiguity. Avoid using long strings (more than three consecutively) of nouns or modifiers. (2; 3; 4) PARAGRAPHS Paragraphs should consist of developed thoughts with each sentence connected to the topic sentence linked to the next paragraph by a logical transition so readers understand how the paragraphs relate. The main point can be stated at the beginning or at the end of the paragraph. Shorter paragraphs are more concise, easier to read, and easier to comprehend. VOICE, TONE, AND STYLE Voice refers to a person s unique word choices and chosen point of view. PDA technical publications are scientific documents written in formal language using the third-person point of view. Authors should strive to maintain third-person point of view throughout these documents. Tone refers to the attitude conveyed by the author in the written piece. PDA technical reports are science- and fact-based documents; therefore, sentences should not convey personal or corporate opinion, conjecture, or editorial content. PDA.org Page 9 of 28

11 Style refers to the way a piece is written, rather than the meaning of the content. Even though most technical reports are written by a team of individual members, all parts of the technical report should blend to reflect a coherent and consistent style (5). POINT OF VIEW Third person tells a story from an outside narrator s point of view. It is the traditional format of academic and report writing as the purpose is to deliver information to the reader. Third person uses pronouns such as he, she, and it. To create a cohesive document, authors should strive to maintain third-person point of view throughout the report so as not to confuse the reader. ACTIVE VS. PASSIVE VOICE In active voice, the subject of the sentence is followed closely by the verb, with the subject performing the action of the verb. Sentences written in active voice tend to be more concise, are more easily understood, and make a stronger statement. Active voice should be used as much as possible in technical reports. In passive voice, the subject receives the action of the verb. In general, using passive voice should be avoided; it often leads to wordier sentences, which can be difficult to follow. Even though acceptable uses of passive voice exist, its use in technical reports should be limited. Sentences should be transposed from passive to active voice wherever possible. CONCISE LANGUAGE The goal in concise writing is to use the most effective words to communicate the message. Using only words in a sentence that are necessary to convey meaning and avoiding nonessential words, particularly adjectives and adverbs, will result in more succinct language. Nominalization, that is, transforming a verb or adjective into a noun by adding ion/tion, ment, ity/ty, ation, or ness, often dilutes the meaning or impact of a word, and should be avoided. For example, using decide rather than make a decision, or intervene instead of hold an intervention strengthens the sentence by adding action. For quick reference, Appendix 2 provides additional information on troublesome sentence structure, punctuation, and word use that is commonly encountered in report writing. HYPHENATION Hyphens can be used to combine two or more words that will be used as a single adjective before a noun (e.g., animal-derived components), to form compound numbers (e.g., forty-three), or to add a prefix to a word (e.g., mid-october). They can also provide clarity when the potential exists for a reader to misunderstand the writer s intent, e.g., re-sign vs. resign. The Merriman-Webster online dictionary provides extensive lists of hyphenated words beginning with prefixes such as non-, pre-, ex-, etc. Some examples of commonly used industry terms are: PDA.org Page 10 of 28

12 Hyphenated Post-approval (adjective) Science-based, risk-based In-process Cross-contamination, cross-flow Re-test Pre-sterilization, non-sterile Cool-down (adjective) Not Hyphenated Prefilled Biowaiver, bioburden Lifecycle Nonconformity Shelf life Standalone (adjective) Log-in/log-off (noun) LISTS NUMBERS VS. BULLETS When writing a report, a list may be the appropriate format to make key information stand out from the text, such as step-by-step instructions. Lists should not stand alone in a report, however; they should be introduced by an explanation or brief description. Numbered lists are generally used when the information is serialized or the text is hierarchical; otherwise, a bulleted list can be used. The use of bullets and lists in technical reports should be minimized. CAPITALIZATION Words should be capitalized when they are proper nouns, that is, when they describe a specific entity; otherwise, lower-case letters are used for common nouns, even if the term has a wellknown acronym, e.g., good manufacturing practices (GMP). EUROPEAN VS. WESTERN SPELLING When there is a regional difference in the spelling of a word, with a few exceptions, PDA uses the Western spelling. If the word is part of a proper name or title, or it is within a quote, the spelling should not be changed (e.g., International Conference on Harmonisation). ACRONYMS The first use of any word that will be referred to by an acronym throughout the report should be spelled out, followed by the acronym in parentheses. Generally, the terms in the text should appear in lower case, such as current good manufacturing practices (cgmp), unless otherwise commonly used by the industry, e.g., Drug Master File (DMF). FIGURES AND TABLES Any images obtained from an outside source, rather than created for a PDA technical report, are considered intellectual property and require written permission for publishing. That includes concepts in diagrams of processes and workflows not created or owned by PDA. If certain photographs, images, etc., are needed to illustrate an idea or a component, such as a photograph of a specific piece of equipment, the TRT Leader(s) must provide the source of the image and documented permission to the S&RA staff. PDA has a licensing agreement for use in securing permissions; it can be found in the Shared Documents folder on the PDA Workspace. The S&RA staff will follow up with the TRT Leader(s) to secure licenses for all graphics, photographs, tables, etc., not created exclusively for the technical report. All drawings and photographs must be submitted to PDA in their original format (JPEG, TIFF, PNG, EPS, etc.); for visual clarity, they must have a resolution of at least 300 dpi. Graphics or images created with a drawing program should be saved as a JPEG or TIFF file, if possible. PDA.org Page 11 of 28

13 Tables created in MS Excel can be transmitted as XLS or XLSX files; graphics created in MS PowerPoint can be sent as PPT or PPTX files. PDA sometimes redesigns figures and tables to meet production requirements and its publishing standards. Clipart and similar graphics generally are not compatible with the tone of PDA technical publications; therefore, PDA reserves the right to exclude artwork not in keeping with its policy for technical reports. PRODUCTION PROOFS Once typesetting is completed, the document is distributed to the TRT Leader(s) and the S&RA staff for final review. All comments, corrections, and recommendations should be submitted to the S&RA staff within five (5) business days of receipt, whenever possible. The S&RA staff will coordinate with the TRT Leader(s) to review modifications. If necessary, a final proof will be distributed to the group so that changes to the first proof can be verified. Note: The proofing cycle is not an opportunity for the TRT to rewrite, add, or delete information from the technical report. That work must be completed prior to the publication stage. References 1. U.S. Copyright Office. 17 USC 107. Limitations on exclusive rights: Fair use. Copyright.gov. [Online] [Cited: Oct 27, 2016.] 2. Philip Rubens, Editor. Science and technical writing: a manual of style, 2nd ed. New York : Routledge, ISBN IEEE Professional Communication Society. Communication Resources for Engineers. IEEE, Advancing Technology for Humanity. [Online] [Cited: Nov 7, 2016.] 4. The Plain Language Action and Information Network (PLAIN). Quick tips to help you write more clearly. Federal Plain Language Guidelines. [Online] March [Cited: Nov 7, 2016.] 5. Wheaton College Writing Center. Style, Diction, Tone, and Voice ( Tone-and-Voice; accessed Oct 2016). PDA.org Page 12 of 28

14 Appendix 1: PDA Technical Report Reference Guide It is important for Task Force members to thoroughly read this document prior to entering references. PDA Task Forces are responsible for ensuring that all references are accurate and complete. Whenever a source is referred to, quoted, borrowed (under fair use) including figures, tables, images, and other artwork, etc., references are needed. This applies even to public sources, such as U.S. FDA guidances, U.S. regulations/laws, and ICH quality guidelines. In every case, if a reference can be accessed online, include the website address. For journal articles, include the Document Online Identifier (DOI) number if available. Task Forces must double check the website addresses and indicate the date the website address was last accessed (more on this below). PDA follows ISO 690 conventions to format the references. The figures below show how to set up each reference within Microsoft Word. 1. Click the References tab and, in the Citations & Bibliography section, click the arrow next to Style. Choose ISO 690 Numerical Reference from the drop down list. PDA.org Page 13 of 28

15 2. Click the 'Insert Citation button and select Add New Source. 3. In the pop-up window, click the arrow next to Type of source and select from the drop down menu, i.e., book, journal article, conference proceedings, website etc. PDA.org Page 14 of 28

16 4. In the pop-up window, select Corporate Author, if appropriate, for organizations such as a regulatory agency or standard-setting organization. 5. Enter the source information into the corresponding fields. If there is a web link to the source, place this and the date the webpage was accessed in the Standard Number field in order o display the information in the reference. PDA.org Page 15 of 28

17 6. If the source is a journal article, book, etc., with multiple authors, click the Edit button next to the Author field. In the, single or multiple author names can be entered. Click OK when complete. 7. There is a Tag field in the bottom left corner of the pop-up window. ISO 690 automatically identifies the source by the first three letters of the author s name and last two digits of the year of publication. ISO 690 requires citations to be unique; if your source is not unique, the citation manager flashes up a message that it will need to be changed. To change the Tag, either change the tag initials or add an alphabetical character after the year. Example: The Tag for a 2010 International Conference on Harmonisation guidance appears as Int10 ; however, your document already contains an entry for the 2010 International Pharmacopeia tagged as Int10. You could change the New Source Tag to ICH10 or to Int10a or something else appropriate. PDA.org Page 16 of 28

18 8. Move to the end of the document where the references will be listed and place the cursor below the 7.0 References heading. Click the Bibliography button and select Insert Bibliography from the drop down menu (prevents the manually typed title of References from being overwritten). 9. The referenced sources will appear at this point, formatted according to ISO 690 specifications. PDA.org Page 17 of 28

19 10. To add more references, follow steps 2-. Technical Report Style Guide For Authors 11. To update the list, right click on any citation entry in the text or in the Reference section, and select Update Field. PDA.org Page 18 of 28

20 12. Citation numbers in the text will adjust automatically and add will appear in the References section. 13. To reference a particular source again in the document, place your cursor at the desired location in the text and click the Insert Citation button. Select the appropriate source from the list. PDA.org Page 19 of 28

21 14. To insert multiple citations for a single instance, position the cursor inside the parentheses of the initial reference number. 15. Click the Insert Citation button and select the source from the list, or add a new reference source. 16. The additional reference number will be added to the text. PDA.org Page 20 of 28

22 17. To remove one of multiple citations, click on the reference numbers, and then click the down arrow in the gray next to the reference numbers. Move your cursor to Remove Citation and select the citation to be removed. 18. A placeholder can be inserted for material that will need a citation source, but the details are not at hand. Click the Insert Citation button, and select Add New Placeholder from the drop down menu. PDA.org Page 21 of 28

23 19. The placeholder can be given a name as a reminder of what material needs to be added. Please note: Placeholder names cannot include spaces. 20. The image below shows two reference placeholders. The details can be added later by clicking on the reference number, selecting Edit Source, and selecting the placeholder to be edited. A pop-up window, like that in step 4, will appear. Enter the information in the corresponding fields, as for any other source. PDA.org Page 22 of 28

24 12. Citation numbers in the text will adjust automatically and add will appear in the References section. 13. To reference a particular source again in the document, place your cursor at the desired location in the text and click the Insert Citation button. Select the appropriate source from the list. PDA.org Page 23 of 28

25 Appendix 2: Quick Reference Grammar and Punctuation Guide SUBJECT-VERB AGREEMENT A verb must agree with its subject in number and person. You requires a plural verb, even if it refers to a single person. Adding s or es to a noun makes it plural; adding s or es to a verb changes it to third person singular. Compound subjects joined by and require a plural verb, unless the connection refers to the same entity, e.g., president and CEO or franks and beans. Two or more subjects joined by and, if preceded by each, every, or many a/an, requires a singular verb. If the subject consists of two or more singular words connected by or, either/or, neither/nor, or not only/but also, the subject is singular and requires a singular verb. If the subject consists of two or more plural words connected by or, either/or, neither/nor, or not only/but also, the subject is plural and requires a plural verb. If the subject consists of two or more plural and singular words, the verb should agree with the word closest to the verb. (Tip: Since plural subjects sound better with plural verbs, organize the sentence so the last subject is plural and use a plural verb.) When trying to determine the agreement between subject and verb, ignore any intervening phrases (usually separated by commas); look only at the subject and verb. When the phrase one of appears in a sentence, e.g., one of those, the subject is singular and requires a singular verb. When a phrase or clause is the subject, the verb is singular, except when the phrase begins with what; then, whether the verb is singular or plural depends on the meaning, e.g., What we need is a new policy vs. What we need are guidelines to follow. PARALLEL STRUCTURE Parallel ideas should be presented in parallel structure, i.e., adjectives should parallel adjectives, nouns should parallel nouns, verbs should parallel verbs, clauses should parallel clauses, etc. Parallelism is especially important in lists, bulleted or numbered. Each line should begin using the same part of speech (e.g., verb, gerund, noun, etc.) and the ending punctuation, if used, should be the same (comma, semicolon, or period). 1 SPLIT INFINITIVES Infinitives consist of the word to and a verb that functions like a noun, adjective, or adverb, for example, to sterilize, or to define. A split infinitive occurs when a word is inserted between to and the verb, such as to effectively sterilize, or to clearly define. Though sometimes it is impossible to avoid splitting an infinitive without changing the intended effect, it is better to avoid using split infinitives in formal writing. 1 Sabin, William. The Gregg Reference Manual: a manual of style, grammar, usage, and formatting, 10th ed. New York: McGraw-Hill/Irwin, PDA.org Page 24 of 28

26 MISPLACED MODIFIERS Modifiers are words or phrases that describe, clarify, or give detail to some part of a sentence. Misplaced modifiers describe an unintended part of the sentence, or an implied word that is not included in the sentence. This frequently happens with introductory phrases and can create a confusing statement or illogical relationship with the subject of the sentence. As a rule, modifiers are best kept as close as possible to the part of speech they are modifying, e.g., a one-word adjective right before the noun it modifies or a modifying phrase immediately preceding or following the item it modifies. Participial phrases most commonly a phrase beginning with a verb + ing generally modify the subject of the sentence. Unless the correct subject is placed immediately after the participial phrase, however, the phrase dangles, modifying the wrong noun. The best strategy to correct a dangling participle or misplaced modifier is to identify in the main clause of the sentence who or what is doing the action, and then revise the sentence to match the modifier with the subject. Another method is to change the introductory phrase to a complete clause that identifies the subject performing the action of the verb. PUNCTUATION Punctuation provides the emphasis in writing that pauses and changes in tone of voice provide in speaking. Knowing what and how to use it lends clarity to written statements. Below is a brief overview of commonly used and misused punctuation and words. Commas, Semicolons, and Colons Writers use commas in numerous ways to separate clauses, elements in a series, nonessential parts of a sentence, and transitional words or phrases, among others to help the reader navigate a sentence or passage. In reports, commas are used most often to: Join two independent clauses (clauses that could stand alone as sentences) and a conjunction Follow an introductory phrase or dependent clause Separate elements in a series (PDA follows the Chicago Manual of Style on serial commas, that is, a comma is placed after every element in a series of three or more, including before a conjunction.) Set off nonessential elements in a sentence Separate coordinate adjectives (adjectives that are equal and reversible) Follow a transitional word or phrase Precede quoted words. Semicolons are used most often to: Separate two independent clauses that closely relate to each other; the clauses would not generally connect using only a coordinating conjunction (e.g., and, but, or so) Join complex clauses with a coordinating conjunction Separate items in a complex list, for instance, when a series of elements already contains commas or extensive phrases Separate two clauses with a conjunctive adverb or transitional phrase. PDA.org Page 25 of 28

27 Colons are used most often to join two independent clauses, when the emphasis should be on the second clause, or when the first clause will be followed by a list or quotation. Commonly Misused Punctuation and Challenging Words Academic degrees Changing case in quotations Company-related abbreviations Serial commas Note parallelism: each item in the series begins with a verb Ellipsis (i.e., ) e.g. i.e. US/U.S./United States Do not use periods to separate letters for doctoral degrees, e.g., JD, PhD, PharmD, MD, DVM. The first letter of the word inside a quoted sentence or phrase may be changed to lower case if quoting inside a sentence, or to upper case if beginning a sentence. Inc. or Ltd., or Inc. Ltd.; but not Inc., Ltd. Place a comma before the conjunction (usually and or or ) in a series of words or phrases, e.g., A design review evaluates deliverables against standards and requirements, identifies problems, and proposes required corrective actions. Three in a series indicates text has been omitted. Four in a series indicates text has been omitted and it is the end of a sentence (usually within a quote). Make sure that the words removed do not alter the basic meaning of the original quote in any way. Means for example Include a comma before and after e.g. when used in a sentence, or after e.g. when beginning a list. Example: required to prepare the medication, e.g., vial-tosyringe transfer, dilution, or use of a filter. Means that is and is equivalent to in other words Include a comma before and after i.e. when used in a sentence, or after when separated from the sentence. Example: (i.e., are testable). In general, spell out US (United States) when used as a noun and keep the acronym US when used as an adjective. Examples: a. (Noun) The book describes the marketing strategy for Japan, European Union, and the United States. b. (Noun, adjective) In the United States, the Drug Amendments Act (1962) required FDA approval for all new US drug applications. c. (Adjective and not part of the official title) The single regulation in the US Code of Federal Regulations. d. (adjective, part of official title) U.S. Government Publishing Office PDA.org Page 26 of 28

28 A vs. an Apostrophes Assure/ensure/insure If the word begins with a vowel sound, use an before the word; if the word begins with a consonant sound, use a before the word, no matter how the word is spelled. 1 Examples: an historic act; an Ouachita city; an hour ago; an LSAT exam; an x-ray Apostrophes create contractions or indicate possession Assure is something you do to a person, a group of people, or an animal to remove doubt or anxiety Ensure is something you do to guarantee an event or condition [will happen] Insure is when something can be done to a person, place, or thing, but it's reserved for limiting financial liability, most commonly by obtaining an insurance policy 2 Coordinating conjunctions If/then Its vs. it s If vs. whether Regardless vs. irregardless Toward vs. towards Use the mnemonic FANBOYS to remember the coordinating conjunctions: for, and, nor, but, or, yet, so. If/then generally reflects a cause/effect relationship. If something happens then something else will happens. In this case, include then in the statement. But omit then in cases such as the following example: Recalibrate if the equipment is continually out of tolerance. It s is a contraction of it is ; its is the possessive form of the pronoun it. Possessives for pronouns do not use an apostrophe. These can sometimes be used interchangeably, though at times the wrong word will change the meaning. The general rule is: Use if when the statement is conditional, e.g., If it rains, the game won t be played. Use whether to show that two alternatives are possible, e.g., I don t know whether the game will be played today or Monday. Irregardless is a nonstandard word (in common use but not a proper word) that some people use to mean regardless. Regardless means without regard ; adding the negative prefix ir creates a double negative (without without regard). In the United States, toward (a person or thing moves toward something) is used with no s ( towards is sometimes used in a less formal context but not in PDA technical reports). Example: This last scenario (plunger movement during injection) occurs because the plunger stopper not only glides upon a silicone layer, but also pushes silicone oil toward the needle upon injection. 1 University of Chicago Press, The Chicago Manual of Style Online, Russell David Harper, ed. Chicago: University of Chicago Press, (accessed October 2016) 2 Carson, Charles. Assure versus Ensure versus Insure. Edited by Mignon Fogarty. Quick and Dirty Tips Website, August 26, (accessed Oct 27, 2016) PDA.org Page 27 of 28